Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Tr... | NCT01685008

NCT01685008

ID	Type	Description	Link
2012-002659-41	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
MOR00208 (formerly Xmab5574)	Experimental	intravenous Infusion of MOR00208, Fc-Optimized Anti-CD19 Antibody	Drug: MOR00208 (formerly Xmab 5574)

Name	Type	Description	Arm Group Labels	Other Names
MOR00208 (formerly Xmab 5574)	Drug		MOR00208 (formerly Xmab5574)	MOR208

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Response Rate (ORR)	Proportion of patients with Complete Remission (CR; disappearance of all evidence of disease) or Partial Remission (PR; regression of measurable disease and no new sites), assessed as per the 2007 International Working Group (IWG) response criteria by radiographic evaluations (CT, PET, MRI, or other).	From first dose until Follow-up Visit 12, up to 4.5 years

Secondary Outcomes

Measure	Description	Time Frame
Stable Disease (SD) Rate	Proportion of patients with Stable Disease (failure to attain CR/PR with no progressive disease)	From first dose until Follow-up Visit 12, up to 4.5 years
Duration of Response (DoR)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female patients ≥ 18 years of age.
Histologically-confirmed diagnosis according to Revised European American Lymphoma/World Health Organization classification, of the following B-cell lymphomas:
1. FL
2. Other indolent NHL (eg, MZL/MALT)
3. DLBCL
4. MCL
Patients' NHL must have progressed after at least 1 prior rituximab containing regimen.
One site of measurable disease by magnetic resonance imaging (MRI) or computed tomography (CT) scan defined as at least one lesion that measures at least 1.5 × 1.5 cm.

Exception:

For patients with MCL only, patients with nonmeasurable disease but evaluable sites (bone marrow, spleen, peripheral blood, gastrointestinal tract) can be enrolled.
Patients who have previously received an autologous stem cell transplantation must be at least 4 weeks post-transplant before study drug administration and must have exhibited a full haematological recovery.
Discontinued previous monoclonal antibody therapy (except rituximab) or radioimmunotherapy administration for at least 60 days before study drug administration.
Off rituximab for at least 14 days before the screening visit and be confirmed to have either no response or have disease progression after rituximab treatment.
Patients with DLBCL had a positive [18F]fluorodeoxyglucose-positron emission tomography (FDG-PET) scan at baseline (Cheson 2007 response criteria).
Life expectancy of > 3 months.
Eastern Cooperative Oncology Group (ECOG) performance status of < 3.
Laboratory criteria at screening:
1. Absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L
2. Platelet count ≥ 75 × 10^9/L without previous transfusion within 10 days of first study drug administration
3. Haemoglobin ≥ 8.0 g/dL (may have been transfused)
4. Serum creatinine < 2.0 x upper limit of normal (ULN)
5. Total bilirubin ≤ 2.0 × ULN
6. Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN
If a female of childbearing potential, a negative pregnancy test must be confirmed before enrolment and use of double-barrier contraception or oral contraceptive plus barrier contraceptive must be used during the study and for 3 months after the last dose, or confirmation of having undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation.
If a male, an effective barrier method of contraception must be used during the study and for 3 months after the last dose if the patient is sexually active with a female of childbearing potential.
Able to comply with all study-related procedures, medication use, and evaluations.
Able to understand and give written informed consent and comply with the study protocol.

Exclusion Criteria:

Previous treatment with cytotoxic chemotherapy, immunotherapy, radiotherapy or other lymphoma specific therapy within 14 days before the screening visit or patient has not recovered from side effects of previous lymphoma-specific therapy.
Treatment with a systemic investigational agent within 28 days before the screening visit.
Previous treatment with an anti-CD19 antibody or fragments.
Previous allogenic stem cell transplantation.
Known or suspected hypersensitivity to the excipients contained in the study drug formulation.
Clinically significant cardiovascular disease or cardiac insufficiency, cardiomyopathy, preexisting clinically significant arrhythmia, acute myocardial infarction within 3 months of enrolment, angina pectoris within 3 months of enrolment.
Patients with positive hepatitis serology:

Hepatitis B (HBV): Patients with positive serology for HBV defined as positivity for hepatitis B surface antigen (HBsAg) or total anti-hepatitis B core antibody (anti-HBc). Patients positive for anti-HBc may be included if HBV DNA is not detectable.

Hepatitis C (HCV): Patients positive HCV serology (defined as positive for anti-HCV antibody [anti-HCV]) unless HCV-ribonucleic acid (RNA) is confirmed negative.
History of HIV infection.
Any active systemic infection (viral, fungal, or bacterial) requiring active parenteral antibiotic therapy within 4 weeks of study drug administration.
Current treatment with immunosuppressive agents other than prescribed corticosteroids (not more than 10-mg prednisone equivalent).
Major surgery or radiation therapy within 4 weeks before first study drug administration.
Systemic diseases (cardiovascular, renal, hepatic, etc) that would prevent study treatment in the investigator's opinion.
History or clinical evidence of central nervous system (CNS), meningeal, or epidural disease, including brain metastasis.
Active treatment/chemotherapy for another primary malignancy within the past 5 years (except for ductal breast cancer in situ, non-melanoma skin cancer, prostate cancer not requiring treatment, and cervical carcinoma in situ).
Pregnancy or breastfeeding in women and women of childbearing potential not using an acceptable method of birth control.
History of noncompliance to medical regimens or patients who are considered potentially unreliable not cooperative.

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
MorphoSys Research Site		Norwalk	Connecticut	06856	United States
MorphoSys Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29444231	Derived	Jurczak W, Zinzani PL, Gaidano G, Goy A, Provencio M, Nagy Z, Robak T, Maddocks K, Buske C, Ambarkhane S, Winderlich M, Dirnberger-Hertweck M, Korolkiewicz R, Blum KA. Phase IIa study of the CD19 antibody MOR208 in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. Ann Oncol. 2018 May 1;29(5):1266-1272. doi: 10.1093/annonc/mdy056.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
FG001	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 26, 2020	Apr 5, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Time from first CR or PR to first documentation of relapse/progression (any new lesion or increase by ≥ 50% of previously identified site)

FG00034 subjects
FG00135 subjects
FG00212 subjects
FG00311 subjects

Per planned analyses, baseline characteristics are summarized by NHL subtype.

Arm/Group Information

ID	Title	Description
BG000	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
BG001	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
BG002	MCL Subtype	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
BG003	Other iNHL	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00034 ParticipantsBG00135 ParticipantsBG00212 ParticipantsBG003

Age, Continuous

Mean

Full Range

years

Title	Denominators	Categories
	ParticipantsBG00034 ParticipantsBG00135 ParticipantsBG002

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00034 ParticipantsBG00135 ParticipantsBG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title	Denominators	Categories
Asian	ParticipantsBG00034 ParticipantsBG00135 ParticipantsBG002

Height

Height was not collected at Screening for 2 patients (minor protocol noncompliance)

Mean

Full Range

Title	Denominators	Categories
	ParticipantsBG00034 ParticipantsBG00133 ParticipantsBG002

Weight

Mean

Full Range

Title	Denominators	Categories
	ParticipantsBG00034 ParticipantsBG00135 ParticipantsBG002

BMI

Height was not collected at Screening for 2 patients (minor protocol noncompliance)

Mean

Full Range

kg/m^2

Title	Denominators	Categories
	ParticipantsBG00034 ParticipantsBG00133 ParticipantsBG002

NHL Subtype

Count of Participants

Participants

Title	Denominators	Categories
Follicular lymphoma	ParticipantsBG00034 ParticipantsBG00135 ParticipantsBG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Overall Response Rate (ORR)

Proportion of patients with Complete Remission (CR; disappearance of all evidence of disease) or Partial Remission (PR; regression of measurable disease and no new sites), assessed as per the 2007 International Working Group (IWG) response criteria by radiographic evaluations (CT, PET, MRI, or other).

The Intent-to-treat (ITT) Population consisted of all patients who received at least one dose of study drug. Patients without any post-Baseline assessment of NHL response were included as non-responders. Per pre-specified analysis plan, efficacy analyses are summarized overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Posted

Count of Participants

Participants

From first dose until Follow-up Visit 12, up to 4.5 years

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG003	MCL Subtype	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG004	Other iNHL	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG005	FL + Other iNHL	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.

Units	Counts
Participants	OG00092 OG00134 OG00235 OG003

Title

Denominators

Categories

Complete remission

Title	Measurements
	OG0006 OG0012 OG0022 OG003

Secondary

Stable Disease (SD) Rate

Proportion of patients with Stable Disease (failure to attain CR/PR with no progressive disease)

The ITT Population consisted of all patients who received at least one dose of study drug. Patients without any post-Baseline assessment of NHL response were included as non-responders. Per pre-specified analysis plan, efficacy analyses are summarized overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Posted

Count of Participants

Participants

From first dose until Follow-up Visit 12, up to 4.5 years

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG003	MCL Subtype

Secondary

Duration of Response (DoR)

Time from first CR or PR to first documentation of relapse/progression (any new lesion or increase by ≥ 50% of previously identified site)

Patients in the ITT Population who had any response (CR or PR) during the study. Per pre-specified analysis plan, efficacy analyses are summarized overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Posted

Median

95% Confidence Interval

months

From first dose until Follow-up Visit 12, up to 4.5 years

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG003	MCL Subtype

Secondary

Time to Progression (TTP)

Time from first dosing until documentation of progression or death due to lymphoma

Patients in the ITT Population with documented progression of disease. Per pre-specified analysis plan, efficacy analyses are summarized overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Posted

Median

95% Confidence Interval

months

From first dose until Follow-up Visit 12, up to 4.5 years

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG003	MCL Subtype	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.

Secondary

Progression-free Survival (PFS)

Time from first dosing until progression or death due to any case

Patients in the ITT Population with documented progression of disease or death from any cause. Per pre-specified analysis plan, efficacy analyses are summarized overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Posted

Median

95% Confidence Interval

months

From first dose until Follow-up Visit 12, up to 4.5 years

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG003	MCL Subtype	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.

Secondary

Incidence and Severity of Adverse Events (AEs)

Number of patients with treatment-emergent AEs rated Mild, Moderate, and Severe

The Safety Population consisted of all patients who received at least one dose of study drug. Per pre-specified analysis plan, adverse event analyses are summarized overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Posted

Count of Participants

Participants

From first dose until 30 days after last dose of MOR00208, up to 8.5 years

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG003	MCL Subtype	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.

Secondary

Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments

Number of patients with at least one positive (+ve) post-Baseline sample containing positive anti-MOR00208 antibodies; Baseline (pre-dose) sample has to be tested negative (-ve)

The Safety Population (all patients who received at least one dose of study drug). Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Posted

Count of Participants

Participants

From first dose until Follow-up Visit 3, up to 7 months

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG003

Secondary

Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of MOR00208

The highest concentration of MOR00208 measured in serum

The PK Population included all patients who had at least one quantifiable serum MOR00208 concentration. PK parameters were calculated as data permitted. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Posted

Mean

Standard Deviation

μg/mL

Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8)

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG003

Secondary

PK Parameter: Time to Maximum Serum Concentration Observed (Tmax) of MOR00208

The time to highest concentration of MOR00208 measured in serum

Posted

Mean

Standard Deviation

hours

Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8)

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG003

Secondary

PK Parameter: Apparent Trough Serum Concentration Before Dosing (Clast) of MOR00208

The last quantifiable concentration from the first dose of MOR00208

Posted

Mean

Standard Deviation

μg/mL

Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8)

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG003

Secondary

PK Parameter: Area Under the Concentration Curve From Dose Time Zero to the Time the Last Quantifiable Concentration is Observed (AUC[0-t]) of MOR00208

Area under the concentration curve. The time curve from time zero (0) to the time that the last concentration above the lower limit of quantification (LLQ) is observed.

Posted

Mean

Standard Deviation

h*μg/mL

Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8)

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.

Secondary

PK Parameter: Area Under the Concentration Curve From Dose Time Zero to Infinity (AUC[0-inf]) of MOR00208

Area under the concentration curve. The time curve from time zero (0) to infinity (inf), where infinity is computed from AUC0-t + [Ct/λZ)]. Ct is calculated from the concentration at the last sampling time at which the sample is above LLQ.

Posted

Mean

Standard Deviation

h*μg/mL

Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.

Secondary

PK Parameter: Apparent Terminal Rate Constant (λz) of MOR00208

Apparent terminal rate constant calculated from the regression analysis (slope) from the log-transformed measured concentrations on the terminal phase of the time-point concentration curve

Posted

Mean

Standard Deviation

1/h

Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.

Secondary

PK Parameter: Apparent Terminal Half-life (t[1/2]) of MOR00208

Apparent terminal half-life calculated from ln(2)/λz

Posted

Mean

Standard Deviation

days

Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG003

Secondary

PK Parameter: Total Body Clearance (CL) of MOR00208

Total body clearance calculated for single or multiple doses: dose(s)/AUC(0-inf)

Posted

Mean

Standard Deviation

L/h

Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG003

Secondary

PK Parameter: Apparent Volume of Distribution (Vz) of MOR00208

Apparent volume of distribution during the terminal phase, calculated from dose/(AUC(0-inf)*λz)

Posted

Mean

Standard Deviation

Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.

Secondary

Absolute Change From Baseline in Measurements of B-cell Populations

Actual change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: B-cell populations

Pharmacodynamic samples were collected at timepoints through the study where possible. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Posted

Median

95% Confidence Interval

10^6 cells/L

Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG003

Secondary

Percent Change From Baseline in Measurements of B-cell Populations

Relative change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: B-cell populations

Posted

Median

95% Confidence Interval

percentage change from baseline

Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG003

Secondary

Absolute Change From Baseline in Measurements of T-cell Populations

Actual change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: T-cell populations

Posted

Median

95% Confidence Interval

10^6 cells/L

Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG003

Secondary

Percent Change From Baseline in Measurements of T-cell Populations

Relative change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: T-cell populations

Posted

Median

95% Confidence Interval

percentage change from baseline

Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG003

Secondary

Absolute Change From Baseline in Measurements of NK Cell Populations

Actual change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: NK cell populations

Posted

Median

95% Confidence Interval

10^6 cells/L

Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG003

Secondary

Percent Change From Baseline in Measurements of NK Cell Populations

Relative change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: NK cell populations

Posted

Median

95% Confidence Interval

percentage change from baseline

Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG003

Secondary

Evaluation of AEs Stratified by Baseline CD19 Expression on Malignant Lymphoma Cells

Incidence of AEs as stratified by presence of CD19 on malignant lymphoma cells detected by tumor biopsy/aspirate during Screening

Per pre-specified analysis plan, if CD19 expression on tumor cells was able to be measured in less than 15% of the ITT population at screening, the stratification analyses by baseline CD19 expression (as planned in the protocol) would not be performed. It was not possible to measure CD19 expression in sufficient cases for such an analysis to be meaningful.

Posted

From first dose until 30 days after last dose of MOR00208, up to 8.5 years

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG003

Secondary

Evaluation of ORR Stratified by Baseline CD19 Expression on Malignant Lymphoma Cells

The analysis of the primary endpoint (ORR) will additionally be stratified by presence of CD19 on malignant lymphoma cells detected by tumor biopsy/aspirate during Screening

Posted

From first dose until Follow-up Visit 12, up to 4.5 years

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG003

Secondary

Evaluation of AEs Stratified by FcγRIIa Polymorphism

Incidence of AEs as stratified by FcγRIIa polymorphism subgroups (genotypes HH, HR, or RR)

Genotyping for FcγRIIa and FcγRIIIa polymorphisms was performed for patients who consented to an optional mucosal cheek swab. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Posted

Number

adverse events

From first dose until 30 days after last dose of MOR00208, up to 8.5 years

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG003	MCL Subtype

Secondary

Evaluation of AEs Stratified by FcγRIIIa Polymorphism

Incidence of AEs as stratified by FcγRIIIa polymorphism subgroups (genotypes FF, FV, or VV)

Posted

Number

adverse events

From first dose until 30 days after last dose of MOR00208, up to 8.5 years

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG003	MCL Subtype

Secondary

Evaluation of ORR Stratified by FcγRIIa Polymorphism

The analysis of the primary endpoint (ORR) will additionally be stratified by FcγRIIa polymorphism subgroups (genotypes HH, HR, or RR)

Posted

Count of Participants

Participants

From first dose until Follow-up Visit 12, up to 4.5 years

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG003	MCL Subtype

Secondary

Evaluation of ORR Stratified by FcγRIIIa Polymorphism

The analysis of the primary endpoint (ORR) will additionally be stratified by FcγRIIIa polymorphism subgroups (genotypes FF, FV, or VV)

Posted

Count of Participants

Participants

From first dose until Follow-up Visit 12, up to 4.5 years

ID	Title	Description
OG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
OG003	MCL Subtype

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Total	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	9	92	30	92	77	92
EG001	FL Subtype	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	1	34	7	34	27	34
EG002	DLBCL Subtype	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	6	35	18	35	31	35
EG003	MCL Subtype	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	2	12	2	12	9	12
EG004	Other iNHL	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	0	11	3	11	10	11
EG005	FL + Other iNHL	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	1	45	10	45	37	45

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 24.0	Systematic Assessment	EG0004 events2 affected92 at risk EG0010 events0 affected34 at risk EG0024 events2 affected35 at risk EG0030 events0 affected12 at risk EG0040 events0 affected11 at risk EG0050 events0 affected45 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA Version 24.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected34 at risk EG0021 events1 affected35 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA Version 24.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected34 at risk EG0021 events1 affected35 at risk EG003
Vision blurred	Eye disorders	MedDRA Version 24.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected34 at risk EG0020 events0 affected35 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA Version 24.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected34 at risk EG0021 events1 affected35 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA Version 24.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected34 at risk EG0021 events1 affected35 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA Version 24.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected34 at risk EG0020 events0 affected35 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA Version 24.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected34 at risk EG0020 events0 affected35 at risk EG003
Device related infection	Infections and infestations	MedDRA Version 24.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected34 at risk EG0020 events0 affected35 at risk EG003
Genital herpes zoster	Infections and infestations	MedDRA Version 24.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected34 at risk EG0021 events1 affected35 at risk EG003
Herpes zoster	Infections and infestations	MedDRA Version 24.0	Systematic Assessment	EG0002 events2 affected92 at risk EG0010 events0 affected34 at risk EG0021 events1 affected35 at risk EG003
Infected bite	Infections and infestations	MedDRA Version 24.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected34 at risk EG0021 events1 affected35 at risk EG003
Pneumococcal infection	Infections and infestations	MedDRA Version 24.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected34 at risk EG0020 events0 affected35 at risk EG003
Pneumonia	Infections and infestations	MedDRA Version 24.0	Systematic Assessment	EG0005 events3 affected92 at risk EG0010 events0 affected34 at risk EG0025 events3 affected35 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA Version 24.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected34 at risk EG0020 events0 affected35 at risk EG003
Fracture	Injury, poisoning and procedural complications	MedDRA Version 24.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected34 at risk EG0020 events0 affected35 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA Version 24.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected34 at risk EG0020 events0 affected35 at risk EG003
Bone cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 24.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected34 at risk EG0021 events1 affected35 at risk EG003
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 24.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected34 at risk EG0020 events0 affected35 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA Version 24.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0011 events1 affected34 at risk EG0020 events0 affected35 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA Version 24.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected34 at risk EG0021 events1 affected35 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 24.0	Systematic Assessment	EG0001 events1 affected92 at risk EG0010 events0 affected34 at risk EG0021 events1 affected35 at risk EG003
Disease progression	General disorders	MedDRA Version 24.0	Systematic Assessment	EG00012 events11 affected92 at risk EG0013 events2 affected34 at risk EG0026 events6 affected35 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 24.0	Systematic Assessment	EG00012 events9 affected92 at risk EG0012 events2 affected34 at risk EG0028 events5 affected35 at risk EG0031 events1 affected12 at risk EG0041 events1 affected11 at risk EG0053 events3 affected45 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 24.0	Systematic Assessment	EG00014 events5 affected92 at risk EG0010 events0 affected34 at risk EG00212 events4 affected35 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA Version 24.0	Systematic Assessment	EG0009 events6 affected92 at risk EG0014 events2 affected34 at risk EG0024 events3 affected35 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA Version 24.0	Systematic Assessment	EG00011 events9 affected92 at risk EG0016 events4 affected34 at risk EG0022 events2 affected35 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA Version 24.0	Systematic Assessment	EG0009 events8 affected92 at risk EG0012 events2 affected34 at risk EG0026 events5 affected35 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA Version 24.0	Systematic Assessment	EG0007 events6 affected92 at risk EG0012 events2 affected34 at risk EG0023 events2 affected35 at risk EG003
Fatigue	General disorders	MedDRA Version 24.0	Systematic Assessment	EG00012 events8 affected92 at risk EG0015 events3 affected34 at risk EG0025 events3 affected35 at risk EG003
Oedema peripheral	General disorders	MedDRA Version 24.0	Systematic Assessment	EG0009 events8 affected92 at risk EG0012 events2 affected34 at risk EG0025 events5 affected35 at risk EG003
Asthenia	General disorders	MedDRA Version 24.0	Systematic Assessment	EG0009 events7 affected92 at risk EG0015 events3 affected34 at risk EG0023 events3 affected35 at risk EG003
Pyrexia	General disorders	MedDRA Version 24.0	Systematic Assessment	EG0008 events5 affected92 at risk EG0012 events2 affected34 at risk EG0022 events1 affected35 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA Version 24.0	Systematic Assessment	EG00014 events11 affected92 at risk EG0019 events7 affected34 at risk EG0025 events4 affected35 at risk EG003
Bronchitis	Infections and infestations	MedDRA Version 24.0	Systematic Assessment	EG0008 events6 affected92 at risk EG0011 events1 affected34 at risk EG0025 events4 affected35 at risk EG003
Infusion-related reaction	Injury, poisoning and procedural complications	MedDRA Version 24.0	Systematic Assessment	EG00015 events12 affected92 at risk EG0014 events4 affected34 at risk EG0026 events4 affected35 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 24.0	Systematic Assessment	EG0007 events7 affected92 at risk EG0012 events2 affected34 at risk EG0022 events2 affected35 at risk EG003
Headache	Nervous system disorders	MedDRA Version 24.0	Systematic Assessment	EG00015 events10 affected92 at risk EG0013 events3 affected34 at risk EG0027 events4 affected35 at risk EG003
Dizziness	Nervous system disorders	MedDRA Version 24.0	Systematic Assessment	EG00011 events9 affected92 at risk EG0014 events4 affected34 at risk EG0023 events2 affected35 at risk EG003
Insomnia	Psychiatric disorders	MedDRA Version 24.0	Systematic Assessment	EG0008 events7 affected92 at risk EG0015 events4 affected34 at risk EG0021 events1 affected35 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 24.0	Systematic Assessment	EG00014 events8 affected92 at risk EG0013 events2 affected34 at risk EG0028 events4 affected35 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 24.0	Systematic Assessment	EG0009 events7 affected92 at risk EG0010 events0 affected34 at risk EG0026 events4 affected35 at risk EG003

ID	Term
D008228	Lymphoma, Non-Hodgkin

Ancestor Terms

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
C000613469	tafasitamab

Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.

EG0040 events0 affected11 at risk

EG0050 events0 affected45 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected45 at risk

EG0040 events0 affected11 at risk

EG0051 events1 affected45 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected45 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected45 at risk

EG0040 events0 affected11 at risk

EG0051 events1 affected45 at risk

EG0040 events0 affected11 at risk

EG0051 events1 affected45 at risk

EG0040 events0 affected11 at risk

EG0051 events1 affected45 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected45 at risk

EG0041 events1 affected11 at risk

EG0051 events1 affected45 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected45 at risk

EG0040 events0 affected11 at risk

EG0051 events1 affected45 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected45 at risk

EG0040 events0 affected11 at risk

EG0051 events1 affected45 at risk

EG0041 events1 affected11 at risk

EG0051 events1 affected45 at risk

EG0040 events0 affected11 at risk

EG0051 events1 affected45 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected45 at risk

EG0040 events0 affected11 at risk

EG0051 events1 affected45 at risk

EG0040 events0 affected11 at risk

EG0051 events1 affected45 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected45 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected45 at risk

EG0041 events1 affected11 at risk

EG0054 events3 affected45 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected45 at risk

EG0040 events0 affected11 at risk

EG0054 events2 affected45 at risk

EG0043 events3 affected11 at risk

EG0059 events7 affected45 at risk

EG0041 events1 affected11 at risk

EG0053 events3 affected45 at risk

EG0041 events1 affected11 at risk

EG0053 events3 affected45 at risk

EG0042 events2 affected11 at risk

EG0057 events5 affected45 at risk

EG0040 events0 affected11 at risk

EG0052 events2 affected45 at risk

EG0040 events0 affected11 at risk

EG0055 events3 affected45 at risk

EG0043 events1 affected11 at risk

EG0055 events3 affected45 at risk

EG0040 events0 affected11 at risk

EG0059 events7 affected45 at risk

EG0042 events1 affected11 at risk

EG0053 events2 affected45 at risk

EG0043 events2 affected11 at risk

EG0057 events6 affected45 at risk

EG0042 events2 affected11 at risk

EG0054 events4 affected45 at risk

EG0044 events2 affected11 at risk

EG0057 events5 affected45 at risk

EG0044 events3 affected11 at risk

EG0058 events7 affected45 at risk

EG0040 events0 affected11 at risk

EG0055 events4 affected45 at risk

EG0043 events2 affected11 at risk

EG0056 events4 affected45 at risk

EG0041 events1 affected11 at risk

EG0051 events1 affected45 at risk

(-214.200 to 7618.000)

OG004-65.00(-108.000 to 13.000)

OG005-65.00(-108.000 to -2.000)

(-77.154 to 1451.048)

OG004-74.47(-81.203 to 118.182)

OG005-76.47(-85.116 to -25.000)

(-219.000 to 600.000)

OG00416.00(-1119.000 to 269.000)

OG00516.00(-98.000 to 85.000)

OG0045.11(-47.800 to 16.205)

OG0051.60(-8.906 to 15.018)

OG0048.00(-300.000 to 70.000)

OG005-20.00(-38.000 to 15.000)

OG00413.79(-48.940 to 194.444)

OG005-8.66(-23.789 to 13.793)