Trial Outcomes & Findings for Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat Non-Hodgkin's Lymphoma (NHL) (NCT NCT01685008)
NCT ID: NCT01685008
Last Updated: 2023-11-07
Results Overview
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).
COMPLETED
PHASE2
92 participants
From first dose until Follow-up Visit 12, up to 4.5 years
2023-11-07
Participant Flow
All patients who fulfilled all the inclusion criteria and none of the exclusion criteria were enrolled and received MOR00208 infusion. Per planned analyses, patient disposition and treatment discontinuation is summarized by NHL subtype.
Participant milestones
| Measure |
FL Subtype
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
|---|---|---|---|---|
|
Main Study Treatment (Cycles 1 - 2)
STARTED
|
34
|
35
|
12
|
11
|
|
Main Study Treatment (Cycles 1 - 2)
COMPLETED
|
30
|
25
|
10
|
10
|
|
Main Study Treatment (Cycles 1 - 2)
NOT COMPLETED
|
4
|
10
|
2
|
1
|
|
Cycle 3 and Maintenance Treatment
STARTED
|
30
|
25
|
10
|
10
|
|
Cycle 3 and Maintenance Treatment
Began Cycle 3 Treatment
|
25
|
13
|
5
|
7
|
|
Cycle 3 and Maintenance Treatment
Entered Maintenance Phase Treatment
|
8
|
6
|
0
|
2
|
|
Cycle 3 and Maintenance Treatment
COMPLETED
|
0
|
1
|
0
|
0
|
|
Cycle 3 and Maintenance Treatment
NOT COMPLETED
|
30
|
24
|
10
|
10
|
Reasons for withdrawal
| Measure |
FL Subtype
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
|---|---|---|---|---|
|
Main Study Treatment (Cycles 1 - 2)
Adverse Event
|
2
|
0
|
0
|
1
|
|
Main Study Treatment (Cycles 1 - 2)
Physician Decision
|
0
|
2
|
0
|
0
|
|
Main Study Treatment (Cycles 1 - 2)
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Main Study Treatment (Cycles 1 - 2)
Progressive Disease
|
2
|
4
|
1
|
0
|
|
Main Study Treatment (Cycles 1 - 2)
Death
|
0
|
3
|
1
|
0
|
Baseline Characteristics
Height was not collected at Screening for 2 patients (minor protocol noncompliance)
Baseline characteristics by cohort
| Measure |
FL Subtype
n=34 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=35 Participants
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=12 Participants
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=11 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=34 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=92 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=34 Participants
|
16 Participants
n=35 Participants
|
6 Participants
n=12 Participants
|
2 Participants
n=11 Participants
|
43 Participants
n=92 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=34 Participants
|
19 Participants
n=35 Participants
|
6 Participants
n=12 Participants
|
9 Participants
n=11 Participants
|
49 Participants
n=92 Participants
|
|
Age, Continuous
|
62.88 years
n=34 Participants
|
66.71 years
n=35 Participants
|
64.92 years
n=12 Participants
|
70.91 years
n=11 Participants
|
65.57 years
n=92 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=34 Participants
|
11 Participants
n=35 Participants
|
1 Participants
n=12 Participants
|
6 Participants
n=11 Participants
|
36 Participants
n=92 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=34 Participants
|
24 Participants
n=35 Participants
|
11 Participants
n=12 Participants
|
5 Participants
n=11 Participants
|
56 Participants
n=92 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=34 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=92 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=34 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=92 Participants
|
|
Race/Ethnicity, Customized
White
|
32 Participants
n=34 Participants
|
33 Participants
n=35 Participants
|
11 Participants
n=12 Participants
|
11 Participants
n=11 Participants
|
87 Participants
n=92 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=34 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
3 Participants
n=92 Participants
|
|
Height
|
170.26 cm
n=34 Participants • Height was not collected at Screening for 2 patients (minor protocol noncompliance)
|
168.24 cm
n=33 Participants • Height was not collected at Screening for 2 patients (minor protocol noncompliance)
|
171.00 cm
n=12 Participants • Height was not collected at Screening for 2 patients (minor protocol noncompliance)
|
167.64 cm
n=11 Participants • Height was not collected at Screening for 2 patients (minor protocol noncompliance)
|
169.30 cm
n=90 Participants • Height was not collected at Screening for 2 patients (minor protocol noncompliance)
|
|
Weight
|
78.62 kg
n=34 Participants
|
75.52 kg
n=35 Participants
|
82.52 kg
n=12 Participants
|
71.53 kg
n=11 Participants
|
77.10 kg
n=92 Participants
|
|
BMI
|
27.26 kg/m^2
n=34 Participants • Height was not collected at Screening for 2 patients (minor protocol noncompliance)
|
26.52 kg/m^2
n=33 Participants • Height was not collected at Screening for 2 patients (minor protocol noncompliance)
|
28.03 kg/m^2
n=12 Participants • Height was not collected at Screening for 2 patients (minor protocol noncompliance)
|
25.36 kg/m^2
n=11 Participants • Height was not collected at Screening for 2 patients (minor protocol noncompliance)
|
26.86 kg/m^2
n=90 Participants • Height was not collected at Screening for 2 patients (minor protocol noncompliance)
|
|
NHL Subtype
Follicular lymphoma
|
34 Participants
n=34 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
34 Participants
n=92 Participants
|
|
NHL Subtype
Diffuse large B-cell lymphoma
|
0 Participants
n=34 Participants
|
35 Participants
n=35 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
35 Participants
n=92 Participants
|
|
NHL Subtype
Mantle cell lymphoma
|
0 Participants
n=34 Participants
|
0 Participants
n=35 Participants
|
12 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
12 Participants
n=92 Participants
|
|
NHL Subtype
Other indolent NHL
|
0 Participants
n=34 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=12 Participants
|
11 Participants
n=11 Participants
|
11 Participants
n=92 Participants
|
PRIMARY outcome
Timeframe: From first dose until Follow-up Visit 12, up to 4.5 yearsPopulation: 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.
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).
Outcome measures
| Measure |
Total
n=92 Participants
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=34 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=35 Participants
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=12 Participants
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=11 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=45 Participants
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.
|
|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR)
Complete remission
|
6 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Overall Response Rate (ORR)
Partial remission
|
16 Participants
|
8 Participants
|
7 Participants
|
0 Participants
|
1 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From first dose until Follow-up Visit 12, up to 4.5 yearsPopulation: 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.
Proportion of patients with Stable Disease (failure to attain CR/PR with no progressive disease)
Outcome measures
| Measure |
Total
n=92 Participants
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=34 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=35 Participants
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=12 Participants
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=11 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=45 Participants
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.
|
|---|---|---|---|---|---|---|
|
Stable Disease (SD) Rate
|
31 Participants
|
16 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: From first dose until Follow-up Visit 12, up to 4.5 yearsPopulation: 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.
Time from first CR or PR to first documentation of relapse/progression (any new lesion or increase by ≥ 50% of previously identified site)
Outcome measures
| Measure |
Total
n=22 Participants
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=10 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=9 Participants
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=3 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=13 Participants
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.
|
|---|---|---|---|---|---|---|
|
Duration of Response (DoR)
|
24.0 months
Interval 11.1 to
Patients who showed a response during the study but did not have documented progression (as described in the pre-specified analysis plan) were considered censored. Due to this statistical data censoring, there was an insufficient number of patients with events in the analysis population to compute median and/or confidence interval(s).
|
24.0 months
Interval 2.6 to
Patients who showed a response during the study but did not have documented progression (as described in the pre-specified analysis plan) were considered censored. Due to this statistical data censoring, there was an insufficient number of patients with events in the analysis population to compute median and/or confidence interval(s).
|
20.1 months
Interval 1.1 to
Patients who showed a response during the study but did not have documented progression (as described in the pre-specified analysis plan) were considered censored. Due to this statistical data censoring, there was an insufficient number of patients with events in the analysis population to compute median and/or confidence interval(s).
|
—
|
NA months
No responders had documented progression, therefore all patients in this population were censored and no median or confidence intervals were applicable.
|
NA months
Interval 3.6 to
Patients who showed a response during the study but did not have documented progression (as described in the pre-specified analysis plan) were considered censored. Due to this statistical data censoring, there was an insufficient number of patients with events in the analysis population to compute median and/or confidence interval(s).
|
SECONDARY outcome
Timeframe: From first dose until Follow-up Visit 12, up to 4.5 yearsPopulation: 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.
Time from first dosing until documentation of progression or death due to lymphoma
Outcome measures
| Measure |
Total
n=76 Participants
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=31 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=25 Participants
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=11 Participants
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=9 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=40 Participants
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.
|
|---|---|---|---|---|---|---|
|
Time to Progression (TTP)
|
5.4 months
Interval 3.4 to 12.0
|
8.8 months
Interval 5.4 to 20.5
|
3.1 months
Interval 2.1 to 15.4
|
3.0 months
Interval 1.8 to
Patients who did not have documented radiological progression (as described in the pre-specified analysis plan) were considered censored. Due to this statistical data censoring, there was an insufficient number of patients with events in the analysis population to compute median and/or confidence interval(s).
|
NA months
Interval 2.0 to
Patients who did not have documented radiological progression (as described in the pre-specified analysis plan) were considered censored. Due to this statistical data censoring, there was an insufficient number of patients with events in the analysis population to compute median and/or confidence interval(s).
|
6.6 months
Interval 5.3 to 20.5
|
SECONDARY outcome
Timeframe: From first dose until Follow-up Visit 12, up to 4.5 yearsPopulation: 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.
Time from first dosing until progression or death due to any case
Outcome measures
| Measure |
Total
n=80 Participants
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=31 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=28 Participants
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=12 Participants
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=9 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=40 Participants
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.
|
|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
5.4 months
Interval 3.2 to 9.9
|
8.8 months
Interval 5.4 to 20.5
|
2.7 months
Interval 2.1 to 13.2
|
2.1 months
Interval 1.7 to
Patients who did not have documented radiological progression, or death occurred beyond a pre-specified time frame (as described in the pre-specified analysis plan) were considered censored. Due to this statistical data censoring, there was an insufficient number of patients with events in the analysis population to compute median and/or confidence interval(s).
|
NA months
Interval 2.0 to
Patients who did not have documented radiological progression, or death occurred beyond a pre-specified time frame (as described in the pre-specified analysis plan) were considered censored. Due to this statistical data censoring, there was an insufficient number of patients with events in the analysis population to compute median and/or confidence interval(s).
|
6.6 months
Interval 5.3 to 20.5
|
SECONDARY outcome
Timeframe: From first dose until 30 days after last dose of MOR00208, up to 8.5 yearsPopulation: 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.
Number of patients with treatment-emergent AEs rated Mild, Moderate, and Severe
Outcome measures
| Measure |
Total
n=92 Participants
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=34 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=35 Participants
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=12 Participants
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=11 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=45 Participants
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.
|
|---|---|---|---|---|---|---|
|
Incidence and Severity of Adverse Events (AEs)
Mild
|
29 Participants
|
10 Participants
|
12 Participants
|
1 Participants
|
6 Participants
|
16 Participants
|
|
Incidence and Severity of Adverse Events (AEs)
Moderate
|
20 Participants
|
8 Participants
|
8 Participants
|
2 Participants
|
2 Participants
|
10 Participants
|
|
Incidence and Severity of Adverse Events (AEs)
Severe
|
6 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From first dose until Follow-up Visit 3, up to 7 monthsPopulation: 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.
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)
Outcome measures
| Measure |
Total
n=92 Participants
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=34 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=35 Participants
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=12 Participants
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=11 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=45 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments
Yes (at least 1 +ve post-Baseline sample, including +ve last sample; Baseline must be -ve)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments
No (Baseline and all post-Baseline samples are -ve)
|
82 Participants
|
31 Participants
|
31 Participants
|
10 Participants
|
10 Participants
|
41 Participants
|
|
Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments
Transient (at least 1 +ve post-Baseline sample but -ve last sample; Baseline must be -ve)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments
Not evaluable (pre-dose Baseline sample tested +ve)
|
5 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments
Missing (no post-Baseline measurement available)
|
5 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 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)Population: 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.
The highest concentration of MOR00208 measured in serum
Outcome measures
| Measure |
Total
n=85 Participants
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=33 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=32 Participants
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=11 Participants
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=9 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=42 Participants
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.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of MOR00208
|
263.1 μg/mL
Standard Deviation 111.35
|
276.6 μg/mL
Standard Deviation 73.10
|
253.4 μg/mL
Standard Deviation 157.79
|
260.0 μg/mL
Standard Deviation 69.85
|
251.5 μg/mL
Standard Deviation 70.31
|
271.2 μg/mL
Standard Deviation 72.42
|
SECONDARY outcome
Timeframe: 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)Population: 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.
The time to highest concentration of MOR00208 measured in serum
Outcome measures
| Measure |
Total
n=85 Participants
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=33 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=32 Participants
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=11 Participants
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=9 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=42 Participants
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.
|
|---|---|---|---|---|---|---|
|
PK Parameter: Time to Maximum Serum Concentration Observed (Tmax) of MOR00208
|
5.8 hours
Standard Deviation 17.46
|
4.7 hours
Standard Deviation 5.27
|
8.5 hours
Standard Deviation 27.99
|
3.0 hours
Standard Deviation 1.03
|
3.4 hours
Standard Deviation 1.38
|
4.4 hours
Standard Deviation 4.72
|
SECONDARY outcome
Timeframe: 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)Population: 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.
The last quantifiable concentration from the first dose of MOR00208
Outcome measures
| Measure |
Total
n=85 Participants
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=33 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=32 Participants
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=11 Participants
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=9 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=42 Participants
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.
|
|---|---|---|---|---|---|---|
|
PK Parameter: Apparent Trough Serum Concentration Before Dosing (Clast) of MOR00208
|
81.0 μg/mL
Standard Deviation 36.66
|
88.6 μg/mL
Standard Deviation 39.50
|
69.6 μg/mL
Standard Deviation 28.96
|
82.4 μg/mL
Standard Deviation 34.54
|
92.2 μg/mL
Standard Deviation 47.23
|
89.3 μg/mL
Standard Deviation 40.69
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Total
n=85 Participants
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=33 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=32 Participants
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=11 Participants
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=9 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=42 Participants
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.
|
|---|---|---|---|---|---|---|
|
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
|
21942.5 h*μg/mL
Standard Deviation 11847.35
|
25088.6 h*μg/mL
Standard Deviation 16245.82
|
19106.3 h*μg/mL
Standard Deviation 8170.03
|
21617.1 h*μg/mL
Standard Deviation 4577.21
|
20888.5 h*μg/mL
Standard Deviation 7669.67
|
24188.6 h*μg/mL
Standard Deviation 14849.65
|
SECONDARY outcome
Timeframe: 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])Population: 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.
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.
Outcome measures
| Measure |
Total
n=91 Participants
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=33 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=35 Participants
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=12 Participants
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=11 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=44 Participants
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.
|
|---|---|---|---|---|---|---|
|
PK Parameter: Area Under the Concentration Curve From Dose Time Zero to Infinity (AUC[0-inf]) of MOR00208
|
NA h*μg/mL
Standard Deviation NA
There were not sufficient data available to allow parameter estimation.
|
NA h*μg/mL
Standard Deviation NA
There were not sufficient data available to allow parameter estimation.
|
NA h*μg/mL
Standard Deviation NA
There were not sufficient data available to allow parameter estimation.
|
NA h*μg/mL
Standard Deviation NA
There were not sufficient data available to allow parameter estimation.
|
NA h*μg/mL
Standard Deviation NA
There were not sufficient data available to allow parameter estimation.
|
NA h*μg/mL
Standard Deviation NA
There were not sufficient data available to allow parameter estimation.
|
SECONDARY outcome
Timeframe: 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])Population: 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.
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
Outcome measures
| Measure |
Total
n=12 Participants
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=9 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=2 Participants
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=1 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=10 Participants
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.
|
|---|---|---|---|---|---|---|
|
PK Parameter: Apparent Terminal Rate Constant (λz) of MOR00208
|
0.00214 1/h
Standard Deviation 0.000665
|
0.00214 1/h
Standard Deviation 0.000707
|
—
|
0.00207 1/h
Standard Deviation 0.000896
|
0.00234 1/h
Standard Deviation NA
Standard deviation is not applicable for a sample size of 1.
|
0.00216 1/h
Standard Deviation 0.000670
|
SECONDARY outcome
Timeframe: 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])Population: 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.
Apparent terminal half-life calculated from ln(2)/λz
Outcome measures
| Measure |
Total
n=12 Participants
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=9 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=2 Participants
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=1 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=10 Participants
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.
|
|---|---|---|---|---|---|---|
|
PK Parameter: Apparent Terminal Half-life (t[1/2]) of MOR00208
|
14.75111 days
Standard Deviation 4.680075
|
14.87185 days
Standard Deviation 4.863339
|
—
|
15.42457 days
Standard Deviation 6.690102
|
12.31761 days
Standard Deviation NA
Standard deviation is not applicable for a sample size of 1.
|
14.61642 days
Standard Deviation 4.655799
|
SECONDARY outcome
Timeframe: 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])Population: 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.
Total body clearance calculated for single or multiple doses: dose(s)/AUC(0-inf)
Outcome measures
| Measure |
Total
n=91 Participants
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=33 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=35 Participants
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=12 Participants
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=11 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=44 Participants
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.
|
|---|---|---|---|---|---|---|
|
PK Parameter: Total Body Clearance (CL) of MOR00208
|
NA L/h
Standard Deviation NA
There were not sufficient data available to allow parameter estimation.
|
NA L/h
Standard Deviation NA
There were not sufficient data available to allow parameter estimation.
|
NA L/h
Standard Deviation NA
There were not sufficient data available to allow parameter estimation.
|
NA L/h
Standard Deviation NA
There were not sufficient data available to allow parameter estimation.
|
NA L/h
Standard Deviation NA
There were not sufficient data available to allow parameter estimation.
|
NA L/h
Standard Deviation NA
There were not sufficient data available to allow parameter estimation.
|
SECONDARY outcome
Timeframe: 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])Population: 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.
Apparent volume of distribution during the terminal phase, calculated from dose/(AUC(0-inf)\*λz)
Outcome measures
| Measure |
Total
n=91 Participants
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=33 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=35 Participants
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=12 Participants
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=11 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=44 Participants
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.
|
|---|---|---|---|---|---|---|
|
PK Parameter: Apparent Volume of Distribution (Vz) of MOR00208
|
NA L
Standard Deviation NA
There were not sufficient data available to allow parameter estimation.
|
NA L
Standard Deviation NA
There were not sufficient data available to allow parameter estimation.
|
NA L
Standard Deviation NA
There were not sufficient data available to allow parameter estimation.
|
NA L
Standard Deviation NA
There were not sufficient data available to allow parameter estimation.
|
NA L
Standard Deviation NA
There were not sufficient data available to allow parameter estimation.
|
NA L
Standard Deviation NA
There were not sufficient data available to allow parameter estimation.
|
SECONDARY outcome
Timeframe: 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)Population: 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.
Actual change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: B-cell populations
Outcome measures
| Measure |
Total
n=70 Participants
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=26 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=31 Participants
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=8 Participants
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=5 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=31 Participants
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.
|
|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Measurements of B-cell Populations
Cycle 2 Day 28
|
-27.68 10^6 cells/L
Interval -59.0 to -8.0
|
-28.00 10^6 cells/L
Interval -115.12 to -0.8
|
-14.50 10^6 cells/L
Interval -35.0 to -1.97
|
-176.85 10^6 cells/L
Interval -661.0 to -28.0
|
-38.00 10^6 cells/L
Interval -120.0 to -4.0
|
-28.00 10^6 cells/L
Interval -94.0 to -3.88
|
|
Absolute Change From Baseline in Measurements of B-cell Populations
Cycle 3 Day 15
|
-36.50 10^6 cells/L
Interval -135.72 to 0.0
|
-33.50 10^6 cells/L
Interval -171.0 to 10.0
|
-22.00 10^6 cells/L
Interval -241.0 to 21.0
|
-256.72 10^6 cells/L
Interval -615.0 to -30.0
|
-77.00 10^6 cells/L
Interval -127.0 to -6.0
|
-35.00 10^6 cells/L
Interval -127.0 to 9.0
|
|
Absolute Change From Baseline in Measurements of B-cell Populations
Cycle 1 Day 8
|
-13.60 10^6 cells/L
Interval -50.25 to -1.0
|
-68.00 10^6 cells/L
Interval -141.0 to -1.0
|
0.00 10^6 cells/L
Interval -13.6 to 10.0
|
-61.13 10^6 cells/L
Interval -214.2 to 7618.0
|
-65.00 10^6 cells/L
Interval -108.0 to 13.0
|
-65.00 10^6 cells/L
Interval -108.0 to -2.0
|
|
Absolute Change From Baseline in Measurements of B-cell Populations
Cycle 1 Day 15
|
-15.00 10^6 cells/L
Interval -55.94 to -3.0
|
-60.50 10^6 cells/L
Interval -171.0 to -10.0
|
-3.00 10^6 cells/L
Interval -15.0 to 6.0
|
-47.00 10^6 cells/L
Interval -687.0 to 26570.0
|
-47.00 10^6 cells/L
Interval -110.0 to 0.0
|
-57.00 10^6 cells/L
Interval -110.02 to -10.0
|
|
Absolute Change From Baseline in Measurements of B-cell Populations
Cycle 1 Day 22
|
-14.00 10^6 cells/L
Interval -57.0 to -4.5
|
-34.00 10^6 cells/L
Interval -148.0 to -6.0
|
-4.25 10^6 cells/L
Interval -19.0 to 0.0
|
-65.01 10^6 cells/L
Interval -680.0 to 1487.0
|
-60.00 10^6 cells/L
Interval -120.0 to 33.0
|
-44.00 10^6 cells/L
Interval -105.98 to -6.0
|
|
Absolute Change From Baseline in Measurements of B-cell Populations
Cycle 2 Day 1
|
-14.00 10^6 cells/L
Interval -51.71 to -3.6
|
-45.00 10^6 cells/L
Interval -141.0 to -2.0
|
-4.00 10^6 cells/L
Interval -17.0 to 1.0
|
-51.71 10^6 cells/L
Interval -697.0 to 2025.0
|
-3.00 10^6 cells/L
Interval -121.0 to 42.0
|
-34.00 10^6 cells/L
Interval -116.39 to -2.0
|
|
Absolute Change From Baseline in Measurements of B-cell Populations
Cycle 2 Day 15
|
-24.00 10^6 cells/L
Interval -61.0 to -12.0
|
-47.50 10^6 cells/L
Interval -181.21 to 0.0
|
-14.25 10^6 cells/L
Interval -23.0 to -4.9
|
-61.45 10^6 cells/L
Interval -673.0 to 9637.0
|
-56.00 10^6 cells/L
Interval -120.0 to 20.0
|
-56.00 10^6 cells/L
Interval -120.0 to -5.5
|
|
Absolute Change From Baseline in Measurements of B-cell Populations
Cycle 3 Day 1
|
-36.00 10^6 cells/L
Interval -117.99 to 0.0
|
-43.00 10^6 cells/L
Interval -171.0 to 5.0
|
-16.00 10^6 cells/L
Interval -238.0 to 0.0
|
-13.06 10^6 cells/L
Interval -718.0 to 2.0
|
-68.00 10^6 cells/L
Interval -129.0 to 16.0
|
-64.00 10^6 cells/L
Interval -129.0 to 5.0
|
|
Absolute Change From Baseline in Measurements of B-cell Populations
Cycle 3 Day 28
|
-46.00 10^6 cells/L
Interval -94.0 to -8.37
|
-60.50 10^6 cells/L
Interval -171.0 to 10.0
|
-16.50 10^6 cells/L
Interval -124.8 to 35.0
|
-43.00 10^6 cells/L
Interval -689.0 to 76.53
|
-59.00 10^6 cells/L
Interval -129.0 to -5.0
|
-60.50 10^6 cells/L
Interval -121.18 to -5.0
|
|
Absolute Change From Baseline in Measurements of B-cell Populations
Study Completion/Early Termination
|
-15.00 10^6 cells/L
Interval -69.82 to 4.0
|
-72.00 10^6 cells/L
Interval -241.0 to 8.0
|
-1.67 10^6 cells/L
Interval -22.1 to 7.0
|
-49.00 10^6 cells/L
Interval -618.0 to 63413.0
|
-40.50 10^6 cells/L
Interval -133.0 to 22.0
|
-72.00 10^6 cells/L
Interval -240.0 to 8.0
|
SECONDARY outcome
Timeframe: 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)Population: 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.
Relative change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: B-cell populations
Outcome measures
| Measure |
Total
n=70 Participants
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=26 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=31 Participants
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=8 Participants
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=5 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=31 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Measurements of B-cell Populations
Cycle 1 Day 15
|
-50.00 percentage change from baseline
Interval -79.422 to -32.353
|
-87.11 percentage change from baseline
Interval -95.947 to -46.341
|
-32.35 percentage change from baseline
Interval -67.442 to 11.429
|
-40.17 percentage change from baseline
Interval -85.16 to 5060.952
|
-50.00 percentage change from baseline
Interval -87.059 to 0.0
|
-82.71 percentage change from baseline
Interval -94.253 to -46.341
|
|
Percent Change From Baseline in Measurements of B-cell Populations
Study Completion/Early Termination
|
-49.31 percentage change from baseline
Interval -85.444 to 2.941
|
-87.00 percentage change from baseline
Interval -95.725 to -14.925
|
-45.44 percentage change from baseline
Interval -52.5 to 37.5
|
-75.09 percentage change from baseline
Interval -93.911 to 1429.186
|
-40.86 percentage change from baseline
Interval -100.0 to 200.0
|
-87.00 percentage change from baseline
Interval -95.122 to 8.696
|
|
Percent Change From Baseline in Measurements of B-cell Populations
Cycle 1 Day 8
|
-42.07 percentage change from baseline
Interval -70.588 to -2.793
|
-80.64 percentage change from baseline
Interval -95.914 to -25.0
|
-0.64 percentage change from baseline
Interval -49.333 to 72.857
|
-40.32 percentage change from baseline
Interval -77.154 to 1451.048
|
-74.47 percentage change from baseline
Interval -81.203 to 118.182
|
-76.47 percentage change from baseline
Interval -85.116 to -25.0
|
|
Percent Change From Baseline in Measurements of B-cell Populations
Cycle 1 Day 22
|
-55.88 percentage change from baseline
Interval -82.625 to -27.5
|
-83.23 percentage change from baseline
Interval -100.0 to -35.8
|
-35.77 percentage change from baseline
Interval -67.857 to -5.714
|
-82.62 percentage change from baseline
Interval -90.556 to 33.514
|
-63.83 percentage change from baseline
Interval -90.226 to 71.739
|
-68.39 percentage change from baseline
Interval -96.279 to -35.8
|
|
Percent Change From Baseline in Measurements of B-cell Populations
Cycle 2 Day 1
|
-55.63 percentage change from baseline
Interval -80.0 to -27.273
|
-82.65 percentage change from baseline
Interval -94.312 to -25.102
|
-40.18 percentage change from baseline
Interval -61.905 to 27.778
|
-72.03 percentage change from baseline
Interval -85.171 to 45.639
|
-27.27 percentage change from baseline
Interval -90.977 to 54.348
|
-80.18 percentage change from baseline
Interval -92.093 to -25.102
|
|
Percent Change From Baseline in Measurements of B-cell Populations
Cycle 2 Day 15
|
-73.80 percentage change from baseline
Interval -83.542 to -57.407
|
-81.98 percentage change from baseline
Interval -100.0 to -35.667
|
-67.32 percentage change from baseline
Interval -83.542 to -31.25
|
-74.07 percentage change from baseline
Interval -93.373 to 217.196
|
-71.76 percentage change from baseline
Interval -100.0 to 43.478
|
-78.05 percentage change from baseline
Interval -97.957 to -57.407
|
|
Percent Change From Baseline in Measurements of B-cell Populations
Cycle 2 Day 28
|
-76.47 percentage change from baseline
Interval -86.458 to -38.095
|
-87.25 percentage change from baseline
Interval -100.0 to -7.143
|
-59.07 percentage change from baseline
Interval -83.415 to -23.529
|
-71.67 percentage change from baseline
Interval -96.062 to -30.769
|
-52.89 percentage change from baseline
Interval -90.226 to -18.085
|
-82.87 percentage change from baseline
Interval -94.419 to -18.085
|
|
Percent Change From Baseline in Measurements of B-cell Populations
Cycle 3 Day 1
|
-79.63 percentage change from baseline
Interval -94.585 to -3.666
|
-93.06 percentage change from baseline
Interval -96.639 to 22.997
|
-82.64 percentage change from baseline
Interval -98.333 to 142.105
|
-3.67 percentage change from baseline
Interval -87.242 to 3.704
|
-76.06 percentage change from baseline
Interval -96.992 to 145.455
|
-79.63 percentage change from baseline
Interval -95.608 to 22.997
|
|
Percent Change From Baseline in Measurements of B-cell Populations
Cycle 3 Day 15
|
-72.07 percentage change from baseline
Interval -93.953 to -33.333
|
-76.61 percentage change from baseline
Interval -96.479 to 48.78
|
-45.24 percentage change from baseline
Interval -94.792 to 110.526
|
-72.07 percentage change from baseline
Interval -74.727 to -55.556
|
-90.59 percentage change from baseline
Interval -95.489 to -54.545
|
-90.59 percentage change from baseline
Interval -96.39 to 0.0
|
|
Percent Change From Baseline in Measurements of B-cell Populations
Cycle 3 Day 28
|
-80.00 percentage change from baseline
Interval -95.833 to -53.191
|
-96.06 percentage change from baseline
Interval -98.193 to -37.085
|
-66.27 percentage change from baseline
Interval -87.847 to 184.211
|
-79.63 percentage change from baseline
Interval -83.718 to 21.484
|
-66.60 percentage change from baseline
Interval -96.992 to -45.455
|
-90.45 percentage change from baseline
Interval -97.611 to -53.191
|
SECONDARY outcome
Timeframe: 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)Population: 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.
Actual change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: T-cell populations
Outcome measures
| Measure |
Total
n=71 Participants
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=26 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=30 Participants
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=9 Participants
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=6 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=32 Participants
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.
|
|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Measurements of T-cell Populations
Cycle 1 Day 8
|
41.00 10^6 cells/L
Interval -3.46 to 89.0
|
12.38 10^6 cells/L
Interval -103.0 to 162.0
|
89.00 10^6 cells/L
Interval 46.0 to 260.0
|
-55.92 10^6 cells/L
Interval -219.0 to 600.0
|
16.00 10^6 cells/L
Interval -1119.0 to 269.0
|
16.00 10^6 cells/L
Interval -98.0 to 85.0
|
|
Absolute Change From Baseline in Measurements of T-cell Populations
Cycle 1 Day 15
|
12.00 10^6 cells/L
Interval -67.0 to 80.0
|
3.00 10^6 cells/L
Interval -301.0 to 123.0
|
28.00 10^6 cells/L
Interval -43.0 to 196.0
|
-22.00 10^6 cells/L
Interval -193.0 to 1042.0
|
-94.00 10^6 cells/L
Interval -1011.0 to 526.0
|
-19.00 10^6 cells/L
Interval -297.79 to 110.0
|
|
Absolute Change From Baseline in Measurements of T-cell Populations
Cycle 1 Day 22
|
-10.00 10^6 cells/L
Interval -70.88 to 34.0
|
-31.00 10^6 cells/L
Interval -180.0 to 34.0
|
26.00 10^6 cells/L
Interval -114.0 to 184.0
|
-3.00 10^6 cells/L
Interval -452.0 to 1129.5
|
-41.00 10^6 cells/L
Interval -252.0 to 71.0
|
-36.00 10^6 cells/L
Interval -180.0 to 26.0
|
|
Absolute Change From Baseline in Measurements of T-cell Populations
Cycle 2 Day 1
|
17.50 10^6 cells/L
Interval -100.0 to 61.0
|
-26.00 10^6 cells/L
Interval -190.0 to 152.0
|
42.50 10^6 cells/L
Interval -105.0 to 94.0
|
-96.00 10^6 cells/L
Interval -531.11 to 127.61
|
-40.00 10^6 cells/L
Interval -537.0 to 844.0
|
-40.00 10^6 cells/L
Interval -137.0 to 111.0
|
|
Absolute Change From Baseline in Measurements of T-cell Populations
Cycle 2 Day 15
|
88.00 10^6 cells/L
Interval -9.0 to 152.0
|
59.98 10^6 cells/L
Interval -117.0 to 153.0
|
72.00 10^6 cells/L
Interval -115.0 to 184.0
|
164.00 10^6 cells/L
Interval -9.0 to 719.03
|
54.50 10^6 cells/L
Interval -28.0 to 422.0
|
59.98 10^6 cells/L
Interval -72.0 to 153.0
|
|
Absolute Change From Baseline in Measurements of T-cell Populations
Cycle 3 Day 15
|
110.00 10^6 cells/L
Interval -27.0 to 318.0
|
94.00 10^6 cells/L
Interval -111.93 to 383.0
|
203.50 10^6 cells/L
Interval -517.0 to 462.0
|
599.00 10^6 cells/L
Interval 143.0 to 770.01
|
-27.00 10^6 cells/L
Interval -212.0 to 112.0
|
80.00 10^6 cells/L
Interval -111.93 to 213.0
|
|
Absolute Change From Baseline in Measurements of T-cell Populations
Cycle 3 Day 28
|
102.45 10^6 cells/L
Interval -40.0 to 243.0
|
72.23 10^6 cells/L
Interval -110.0 to 448.0
|
198.31 10^6 cells/L
Interval -403.0 to 696.0
|
131.00 10^6 cells/L
Interval -131.0 to 1279.07
|
72.50 10^6 cells/L
Interval -78.0 to 366.0
|
72.50 10^6 cells/L
Interval -40.0 to 366.0
|
|
Absolute Change From Baseline in Measurements of T-cell Populations
Cycle 2 Day 28
|
99.00 10^6 cells/L
Interval -17.0 to 250.0
|
32.87 10^6 cells/L
Interval -120.8 to 286.0
|
176.64 10^6 cells/L
Interval -142.0 to 386.0
|
133.00 10^6 cells/L
Interval 39.32 to 1051.41
|
108.00 10^6 cells/L
Interval -103.0 to 365.0
|
38.00 10^6 cells/L
Interval -69.0 to 259.0
|
|
Absolute Change From Baseline in Measurements of T-cell Populations
Cycle 3 Day 1
|
58.00 10^6 cells/L
Interval -69.0 to 158.5
|
45.00 10^6 cells/L
Interval -140.0 to 267.0
|
115.00 10^6 cells/L
Interval -100.0 to 222.7
|
174.00 10^6 cells/L
Interval 96.0 to 889.09
|
-32.00 10^6 cells/L
Interval -203.0 to 90.0
|
-4.00 10^6 cells/L
Interval -140.0 to 158.5
|
|
Absolute Change From Baseline in Measurements of T-cell Populations
Study Completion/Early Termination
|
-57.50 10^6 cells/L
Interval -137.0 to 144.0
|
-104.00 10^6 cells/L
Interval -224.0 to 228.47
|
-84.00 10^6 cells/L
Interval -305.0 to 139.0
|
165.00 10^6 cells/L
Interval -174.0 to 361.17
|
361.50 10^6 cells/L
Interval -1079.0 to 2592.0
|
-55.00 10^6 cells/L
Interval -224.0 to 411.0
|
SECONDARY outcome
Timeframe: 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)Population: 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.
Relative change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: T-cell populations
Outcome measures
| Measure |
Total
n=71 Participants
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=26 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=30 Participants
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=9 Participants
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=6 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=32 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Measurements of T-cell Populations
Cycle 1 Day 15
|
1.75 percentage change from baseline
Interval -9.999 to 12.312
|
1.25 percentage change from baseline
Interval -17.2 to 14.604
|
8.81 percentage change from baseline
Interval -15.314 to 44.118
|
-4.01 percentage change from baseline
Interval -26.187 to 145.125
|
-17.49 percentage change from baseline
Interval -43.187 to 31.687
|
-1.99 percentage change from baseline
Interval -17.491 to 12.312
|
|
Percent Change From Baseline in Measurements of T-cell Populations
Cycle 2 Day 15
|
10.39 percentage change from baseline
Interval -1.17 to 22.944
|
7.34 percentage change from baseline
Interval -11.716 to 23.043
|
15.35 percentage change from baseline
Interval -11.358 to 38.971
|
12.25 percentage change from baseline
Interval -1.17 to 107.003
|
3.46 percentage change from baseline
Interval -7.91 to 18.026
|
6.82 percentage change from baseline
Interval -7.91 to 22.944
|
|
Percent Change From Baseline in Measurements of T-cell Populations
Cycle 2 Day 28
|
9.91 percentage change from baseline
Interval -3.321 to 30.339
|
5.96 percentage change from baseline
Interval -8.938 to 29.916
|
36.51 percentage change from baseline
Interval -10.132 to 73.662
|
20.58 percentage change from baseline
Interval 5.666 to 156.467
|
17.52 percentage change from baseline
Interval -29.096 to 64.488
|
7.64 percentage change from baseline
Interval -7.24 to 27.157
|
|
Percent Change From Baseline in Measurements of T-cell Populations
Cycle 1 Day 8
|
7.28 percentage change from baseline
Interval -0.394 to 16.991
|
1.59 percentage change from baseline
Interval -8.906 to 18.456
|
17.07 percentage change from baseline
Interval 10.242 to 37.132
|
-7.26 percentage change from baseline
Interval -35.371 to 83.565
|
5.11 percentage change from baseline
Interval -47.8 to 16.205
|
1.60 percentage change from baseline
Interval -8.906 to 15.018
|
|
Percent Change From Baseline in Measurements of T-cell Populations
Cycle 1 Day 22
|
-1.63 percentage change from baseline
Interval -10.213 to 6.436
|
-1.83 percentage change from baseline
Interval -13.413 to 6.436
|
5.62 percentage change from baseline
Interval -20.394 to 39.28
|
-0.41 percentage change from baseline
Interval -82.332 to 168.088
|
-10.76 percentage change from baseline
Interval -38.693 to 22.684
|
-3.17 percentage change from baseline
Interval -13.012 to 4.361
|
|
Percent Change From Baseline in Measurements of T-cell Populations
Cycle 2 Day 1
|
2.93 percentage change from baseline
Interval -12.484 to 12.025
|
-1.63 percentage change from baseline
Interval -17.286 to 14.765
|
10.38 percentage change from baseline
Interval -7.023 to 20.524
|
-12.48 percentage change from baseline
Interval -76.529 to 14.538
|
-12.78 percentage change from baseline
Interval -38.701 to 50.843
|
-2.36 percentage change from baseline
Interval -17.286 to 14.765
|
|
Percent Change From Baseline in Measurements of T-cell Populations
Cycle 3 Day 1
|
12.99 percentage change from baseline
Interval -6.114 to 23.81
|
9.60 percentage change from baseline
Interval -9.799 to 27.929
|
18.67 percentage change from baseline
Interval -7.159 to 43.226
|
17.49 percentage change from baseline
Interval 12.995 to 132.311
|
-2.37 percentage change from baseline
Interval -35.866 to 28.754
|
-1.13 percentage change from baseline
Interval -9.799 to 27.929
|
|
Percent Change From Baseline in Measurements of T-cell Populations
Cycle 3 Day 15
|
20.09 percentage change from baseline
Interval -7.627 to 34.934
|
9.57 percentage change from baseline
Interval -12.21 to 34.934
|
20.66 percentage change from baseline
Interval -14.13 to 100.873
|
44.73 percentage change from baseline
Interval 26.047 to 114.59
|
-7.63 percentage change from baseline
Interval -37.456 to 35.783
|
6.38 percentage change from baseline
Interval -12.21 to 34.934
|
|
Percent Change From Baseline in Measurements of T-cell Populations
Cycle 3 Day 28
|
17.34 percentage change from baseline
Interval -9.783 to 26.905
|
11.37 percentage change from baseline
Interval -13.423 to 33.794
|
21.90 percentage change from baseline
Interval -18.26 to 151.965
|
23.86 percentage change from baseline
Interval -9.783 to 190.346
|
17.10 percentage change from baseline
Interval -13.781 to 32.588
|
14.15 percentage change from baseline
Interval -11.156 to 32.588
|
|
Percent Change From Baseline in Measurements of T-cell Populations
Study Completion/Early Termination
|
-8.07 percentage change from baseline
Interval -14.994 to 26.912
|
-12.80 percentage change from baseline
Interval -18.456 to 29.129
|
-8.07 percentage change from baseline
Interval -42.093 to 32.548
|
12.32 percentage change from baseline
Interval -31.694 to 52.042
|
28.31 percentage change from baseline
Interval -65.0 to 457.951
|
-12.21 percentage change from baseline
Interval -18.456 to 29.712
|
SECONDARY outcome
Timeframe: 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)Population: 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.
Actual change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: NK cell populations
Outcome measures
| Measure |
Total
n=71 Participants
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=26 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=30 Participants
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=9 Participants
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=6 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=32 Participants
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.
|
|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Measurements of NK Cell Populations
Cycle 1 Day 8
|
-2.20 10^6 cells/L
Interval -21.0 to 15.0
|
-20.00 10^6 cells/L
Interval -38.0 to 15.0
|
20.00 10^6 cells/L
Interval -10.0 to 41.0
|
-59.50 10^6 cells/L
Interval -113.86 to 6.57
|
8.00 10^6 cells/L
Interval -300.0 to 70.0
|
-20.00 10^6 cells/L
Interval -38.0 to 15.0
|
|
Absolute Change From Baseline in Measurements of NK Cell Populations
Cycle 1 Day 15
|
-23.00 10^6 cells/L
Interval -43.0 to 11.0
|
-36.99 10^6 cells/L
Interval -67.0 to 28.09
|
-4.00 10^6 cells/L
Interval -26.25 to 23.0
|
-33.00 10^6 cells/L
Interval -216.0 to 117.0
|
-79.00 10^6 cells/L
Interval -211.0 to 66.0
|
-38.97 10^6 cells/L
Interval -73.0 to 20.0
|
|
Absolute Change From Baseline in Measurements of NK Cell Populations
Cycle 1 Day 22
|
-18.00 10^6 cells/L
Interval -38.0 to 7.55
|
-28.00 10^6 cells/L
Interval -48.0 to 7.55
|
27.06 10^6 cells/L
Interval -24.0 to 71.0
|
-133.68 10^6 cells/L
Interval -248.0 to -6.44
|
-60.00 10^6 cells/L
Interval -345.0 to 42.0
|
-30.00 10^6 cells/L
Interval -60.0 to 6.0
|
|
Absolute Change From Baseline in Measurements of NK Cell Populations
Cycle 2 Day 1
|
-16.32 10^6 cells/L
Interval -33.0 to 9.89
|
-11.01 10^6 cells/L
Interval -39.73 to 21.0
|
-21.31 10^6 cells/L
Interval -37.0 to 19.0
|
-64.00 10^6 cells/L
Interval -249.0 to 556.03
|
-1.00 10^6 cells/L
Interval -146.0 to 135.0
|
-7.00 10^6 cells/L
Interval -31.0 to 21.0
|
|
Absolute Change From Baseline in Measurements of NK Cell Populations
Cycle 2 Day 15
|
-19.00 10^6 cells/L
Interval -32.0 to 16.8
|
6.00 10^6 cells/L
Interval -29.0 to 35.0
|
-14.00 10^6 cells/L
Interval -47.45 to 72.0
|
-116.65 10^6 cells/L
Interval -144.0 to 199.59
|
-51.50 10^6 cells/L
Interval -231.0 to 5.0
|
-7.00 10^6 cells/L
Interval -29.0 to 27.37
|
|
Absolute Change From Baseline in Measurements of NK Cell Populations
Cycle 2 Day 28
|
-1.00 10^6 cells/L
Interval -18.0 to 51.0
|
-3.00 10^6 cells/L
Interval -23.98 to 48.0
|
52.00 10^6 cells/L
Interval -31.0 to 76.0
|
-93.00 10^6 cells/L
Interval -181.27 to 10.43
|
9.50 10^6 cells/L
Interval -260.0 to 245.0
|
-3.00 10^6 cells/L
Interval -23.98 to 48.0
|
|
Absolute Change From Baseline in Measurements of NK Cell Populations
Cycle 3 Day 1
|
-23.00 10^6 cells/L
Interval -66.0 to -3.0
|
-10.00 10^6 cells/L
Interval -37.0 to 10.74
|
-11.76 10^6 cells/L
Interval -75.0 to 58.0
|
-104.00 10^6 cells/L
Interval -111.26 to -66.0
|
-80.00 10^6 cells/L
Interval -378.0 to 189.0
|
-23.00 10^6 cells/L
Interval -66.0 to 10.74
|
|
Absolute Change From Baseline in Measurements of NK Cell Populations
Cycle 3 Day 15
|
-33.00 10^6 cells/L
Interval -70.0 to -2.0
|
-27.50 10^6 cells/L
Interval -63.0 to 41.0
|
-46.00 10^6 cells/L
Interval -75.8 to 158.0
|
-99.00 10^6 cells/L
Interval -153.31 to -24.0
|
-84.00 10^6 cells/L
Interval -97.0 to 88.0
|
-29.00 10^6 cells/L
Interval -67.0 to 41.0
|
|
Absolute Change From Baseline in Measurements of NK Cell Populations
Cycle 3 Day 28
|
-15.00 10^6 cells/L
Interval -32.0 to 11.0
|
-5.66 10^6 cells/L
Interval -28.0 to 51.0
|
0.62 10^6 cells/L
Interval -58.0 to 108.0
|
-70.00 10^6 cells/L
Interval -115.0 to -57.02
|
-13.50 10^6 cells/L
Interval -93.0 to 103.0
|
-13.50 10^6 cells/L
Interval -28.0 to 51.0
|
|
Absolute Change From Baseline in Measurements of NK Cell Populations
Study Completion/Early Termination
|
-11.00 10^6 cells/L
Interval -35.0 to 2.0
|
-11.50 10^6 cells/L
Interval -35.0 to -2.0
|
-20.74 10^6 cells/L
Interval -181.99 to 13.26
|
1.15 10^6 cells/L
Interval -242.0 to 151.0
|
22.00 10^6 cells/L
Interval -463.0 to 1924.0
|
-9.00 10^6 cells/L
Interval -35.0 to 8.0
|
SECONDARY outcome
Timeframe: 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)Population: 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.
Relative change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: NK cell populations
Outcome measures
| Measure |
Total
n=71 Participants
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=26 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=30 Participants
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=9 Participants
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=6 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=32 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Measurements of NK Cell Populations
Cycle 1 Day 8
|
-1.62 percentage change from baseline
Interval -18.261 to 11.429
|
-11.58 percentage change from baseline
Interval -23.789 to 6.122
|
13.16 percentage change from baseline
Interval -16.393 to 36.19
|
-32.20 percentage change from baseline
Interval -43.326 to 3.99
|
13.79 percentage change from baseline
Interval -48.94 to 194.444
|
-8.66 percentage change from baseline
Interval -23.789 to 13.793
|
|
Percent Change From Baseline in Measurements of NK Cell Populations
Cycle 1 Day 15
|
-18.85 percentage change from baseline
Interval -24.046 to 11.364
|
-22.39 percentage change from baseline
Interval -29.63 to 17.918
|
-1.14 percentage change from baseline
Interval -21.078 to 33.333
|
-25.78 percentage change from baseline
Interval -50.781 to 103.54
|
-32.11 percentage change from baseline
Interval -49.421 to 183.333
|
-22.45 percentage change from baseline
Interval -32.114 to 17.918
|
|
Percent Change From Baseline in Measurements of NK Cell Populations
Cycle 1 Day 22
|
-13.38 percentage change from baseline
Interval -29.688 to 3.027
|
-13.38 percentage change from baseline
Interval -39.053 to 3.027
|
18.16 percentage change from baseline
Interval -36.667 to 69.88
|
-50.87 percentage change from baseline
Interval -78.0 to -4.347
|
-36.21 percentage change from baseline
Interval -56.281 to 116.667
|
-14.59 percentage change from baseline
Interval -39.053 to 2.597
|
|
Percent Change From Baseline in Measurements of NK Cell Populations
Cycle 2 Day 1
|
-11.17 percentage change from baseline
Interval -23.478 to 5.634
|
-8.03 percentage change from baseline
Interval -25.573 to 11.896
|
-14.97 percentage change from baseline
Interval -24.74 to 17.297
|
-50.00 percentage change from baseline
Interval -53.667 to 337.684
|
-0.16 percentage change from baseline
Interval -56.371 to 141.667
|
-6.48 percentage change from baseline
Interval -25.573 to 11.896
|
|
Percent Change From Baseline in Measurements of NK Cell Populations
Cycle 2 Day 15
|
-8.11 percentage change from baseline
Interval -22.467 to 20.314
|
9.03 percentage change from baseline
Interval -22.467 to 22.727
|
-7.13 percentage change from baseline
Interval -31.429 to 60.0
|
-41.00 percentage change from baseline
Interval -56.25 to 134.731
|
-20.08 percentage change from baseline
Interval -37.684 to 8.621
|
-1.51 percentage change from baseline
Interval -22.467 to 20.37
|
|
Percent Change From Baseline in Measurements of NK Cell Populations
Cycle 2 Day 28
|
-1.92 percentage change from baseline
Interval -14.762 to 29.73
|
-4.23 percentage change from baseline
Interval -15.909 to 19.592
|
32.57 percentage change from baseline
Interval -14.762 to 73.729
|
-48.44 percentage change from baseline
Interval -68.976 to 6.334
|
35.32 percentage change from baseline
Interval -42.414 to 261.111
|
-4.23 percentage change from baseline
Interval -15.909 to 19.592
|
|
Percent Change From Baseline in Measurements of NK Cell Populations
Cycle 3 Day 1
|
-14.08 percentage change from baseline
Interval -26.866 to -1.115
|
-12.83 percentage change from baseline
Interval -25.191 to 12.987
|
-8.33 percentage change from baseline
Interval -35.545 to 50.0
|
-42.34 percentage change from baseline
Interval -51.563 to -34.667
|
-31.97 percentage change from baseline
Interval -61.664 to 525.0
|
-13.22 percentage change from baseline
Interval -26.866 to 12.987
|
|
Percent Change From Baseline in Measurements of NK Cell Populations
Cycle 3 Day 15
|
-20.13 percentage change from baseline
Interval -38.253 to -1.136
|
-17.76 percentage change from baseline
Interval -40.845 to 18.062
|
-16.17 percentage change from baseline
Interval -39.336 to 124.576
|
-33.00 percentage change from baseline
Interval -58.337 to -18.75
|
-32.43 percentage change from baseline
Interval -39.431 to 244.444
|
-20.37 percentage change from baseline
Interval -39.431 to 18.062
|
|
Percent Change From Baseline in Measurements of NK Cell Populations
Cycle 3 Day 28
|
-6.10 percentage change from baseline
Interval -21.697 to 17.0
|
-2.72 percentage change from baseline
Interval -24.426 to 19.872
|
1.78 percentage change from baseline
Interval -28.409 to 91.525
|
-38.33 percentage change from baseline
Interval -54.688 to -21.697
|
-5.37 percentage change from baseline
Interval -15.171 to 286.111
|
-5.37 percentage change from baseline
Interval -18.182 to 19.872
|
|
Percent Change From Baseline in Measurements of NK Cell Populations
Study Completion/Early Termination
|
-11.01 percentage change from baseline
Interval -28.906 to 6.667
|
-11.06 percentage change from baseline
Interval -28.333 to -0.866
|
-23.94 percentage change from baseline
Interval -62.726 to 16.667
|
0.78 percentage change from baseline
Interval -80.667 to 86.979
|
42.15 percentage change from baseline
Interval -75.53 to 782.114
|
-10.49 percentage change from baseline
Interval -28.333 to 22.222
|
SECONDARY outcome
Timeframe: From first dose until 30 days after last dose of MOR00208, up to 8.5 yearsPopulation: 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.
Incidence of AEs as stratified by presence of CD19 on malignant lymphoma cells detected by tumor biopsy/aspirate during Screening
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose until Follow-up Visit 12, up to 4.5 yearsPopulation: 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.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose until 30 days after last dose of MOR00208, up to 8.5 yearsPopulation: 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.
Incidence of AEs as stratified by FcγRIIa polymorphism subgroups (genotypes HH, HR, or RR)
Outcome measures
| Measure |
Total
n=74 Participants
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=25 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=32 Participants
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=10 Participants
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=7 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=32 Participants
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.
|
|---|---|---|---|---|---|---|
|
Evaluation of AEs Stratified by FcγRIIa Polymorphism
Genotype HH
|
210 adverse events
|
64 adverse events
|
109 adverse events
|
29 adverse events
|
8 adverse events
|
72 adverse events
|
|
Evaluation of AEs Stratified by FcγRIIa Polymorphism
Genotype HR
|
188 adverse events
|
83 adverse events
|
51 adverse events
|
6 adverse events
|
48 adverse events
|
131 adverse events
|
|
Evaluation of AEs Stratified by FcγRIIa Polymorphism
Genotype RR
|
61 adverse events
|
5 adverse events
|
44 adverse events
|
4 adverse events
|
8 adverse events
|
13 adverse events
|
SECONDARY outcome
Timeframe: From first dose until 30 days after last dose of MOR00208, up to 8.5 yearsPopulation: 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.
Incidence of AEs as stratified by FcγRIIIa polymorphism subgroups (genotypes FF, FV, or VV)
Outcome measures
| Measure |
Total
n=74 Participants
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=25 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=32 Participants
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=10 Participants
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=7 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=32 Participants
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.
|
|---|---|---|---|---|---|---|
|
Evaluation of AEs Stratified by FcγRIIIa Polymorphism
Genotype VV
|
200 adverse events
|
26 adverse events
|
112 adverse events
|
6 adverse events
|
56 adverse events
|
82 adverse events
|
|
Evaluation of AEs Stratified by FcγRIIIa Polymorphism
Genotype FF
|
110 adverse events
|
51 adverse events
|
59 adverse events
|
0 adverse events
|
0 adverse events
|
51 adverse events
|
|
Evaluation of AEs Stratified by FcγRIIIa Polymorphism
Genotype FV
|
149 adverse events
|
75 adverse events
|
33 adverse events
|
33 adverse events
|
8 adverse events
|
83 adverse events
|
SECONDARY outcome
Timeframe: From first dose until Follow-up Visit 12, up to 4.5 yearsPopulation: 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.
The analysis of the primary endpoint (ORR) will additionally be stratified by FcγRIIa polymorphism subgroups (genotypes HH, HR, or RR)
Outcome measures
| Measure |
Total
n=74 Participants
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=25 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=32 Participants
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=10 Participants
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=7 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=32 Participants
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.
|
|---|---|---|---|---|---|---|
|
Evaluation of ORR Stratified by FcγRIIa Polymorphism
Genotype HH
|
6 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Evaluation of ORR Stratified by FcγRIIa Polymorphism
Genotype HR
|
8 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
|
Evaluation of ORR Stratified by FcγRIIa Polymorphism
Genotype RR
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From first dose until Follow-up Visit 12, up to 4.5 yearsPopulation: 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.
The analysis of the primary endpoint (ORR) will additionally be stratified by FcγRIIIa polymorphism subgroups (genotypes FF, FV, or VV)
Outcome measures
| Measure |
Total
n=74 Participants
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=25 Participants
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=32 Participants
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=10 Participants
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=7 Participants
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=32 Participants
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.
|
|---|---|---|---|---|---|---|
|
Evaluation of ORR Stratified by FcγRIIIa Polymorphism
Genotype FV
|
5 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Evaluation of ORR Stratified by FcγRIIIa Polymorphism
Genotype FF
|
10 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
|
Evaluation of ORR Stratified by FcγRIIIa Polymorphism
Genotype VV
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
Adverse Events
Total
FL Subtype
DLBCL Subtype
MCL Subtype
Other iNHL
FL + Other iNHL
Serious adverse events
| Measure |
Total
n=92 participants at risk
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=34 participants at risk
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=35 participants at risk
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=12 participants at risk
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=11 participants at risk
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=45 participants at risk
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.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.2%
2/92 • Number of events 4 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/34 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
5.7%
2/35 • Number of events 4 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/45 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/34 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/45 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Cardiac disorders
Cardiac failure
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/34 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/45 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Eye disorders
Vision blurred
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/35 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/34 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/45 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Gastrointestinal disorders
Colitis
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/34 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/45 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/35 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/35 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Infections and infestations
Device related infection
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/35 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Infections and infestations
Genital herpes zoster
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/34 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/45 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Infections and infestations
Herpes zoster
|
2.2%
2/92 • Number of events 2 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/34 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Infections and infestations
Infected bite
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/34 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/45 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Infections and infestations
Pneumococcal infection
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/35 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Infections and infestations
Pneumonia
|
3.3%
3/92 • Number of events 5 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/34 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
8.6%
3/35 • Number of events 5 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/45 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Infections and infestations
Respiratory tract infection
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/35 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Injury, poisoning and procedural complications
Fracture
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/34 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/35 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/35 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/34 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/45 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/35 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Renal and urinary disorders
Acute kidney injury
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/35 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Renal and urinary disorders
Ureterolithiasis
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/34 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/45 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
1/92 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/34 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/45 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
General disorders
Disease progression
|
12.0%
11/92 • Number of events 12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
5.9%
2/34 • Number of events 3 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
17.1%
6/35 • Number of events 6 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
6.7%
3/45 • Number of events 4 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
Other adverse events
| Measure |
Total
n=92 participants at risk
All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL Subtype
n=34 participants at risk
Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
DLBCL Subtype
n=35 participants at risk
Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
MCL Subtype
n=12 participants at risk
Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
Other iNHL
n=11 participants at risk
Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
|
FL + Other iNHL
n=45 participants at risk
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.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
9.8%
9/92 • Number of events 12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
14.3%
5/35 • Number of events 8 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
6.7%
3/45 • Number of events 3 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.4%
5/92 • Number of events 14 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/34 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
11.4%
4/35 • Number of events 12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
8.3%
1/12 • Number of events 2 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/45 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
6.5%
6/92 • Number of events 9 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
5.9%
2/34 • Number of events 4 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
8.6%
3/35 • Number of events 4 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
4.4%
2/45 • Number of events 4 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Gastrointestinal disorders
Nausea
|
9.8%
9/92 • Number of events 11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
11.8%
4/34 • Number of events 6 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
5.7%
2/35 • Number of events 2 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
27.3%
3/11 • Number of events 3 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
15.6%
7/45 • Number of events 9 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Gastrointestinal disorders
Diarrhoea
|
8.7%
8/92 • Number of events 9 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
14.3%
5/35 • Number of events 6 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
6.7%
3/45 • Number of events 3 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Gastrointestinal disorders
Constipation
|
6.5%
6/92 • Number of events 7 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
5.7%
2/35 • Number of events 3 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
6.7%
3/45 • Number of events 3 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
General disorders
Fatigue
|
8.7%
8/92 • Number of events 12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
8.8%
3/34 • Number of events 5 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
8.6%
3/35 • Number of events 5 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
18.2%
2/11 • Number of events 2 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
11.1%
5/45 • Number of events 7 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
General disorders
Oedema peripheral
|
8.7%
8/92 • Number of events 9 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
14.3%
5/35 • Number of events 5 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
8.3%
1/12 • Number of events 2 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
4.4%
2/45 • Number of events 2 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
General disorders
Asthenia
|
7.6%
7/92 • Number of events 9 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
8.8%
3/34 • Number of events 5 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
8.6%
3/35 • Number of events 3 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
6.7%
3/45 • Number of events 5 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
General disorders
Pyrexia
|
5.4%
5/92 • Number of events 8 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.9%
1/35 • Number of events 2 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
9.1%
1/11 • Number of events 3 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
6.7%
3/45 • Number of events 5 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Infections and infestations
Upper respiratory tract infection
|
12.0%
11/92 • Number of events 14 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
20.6%
7/34 • Number of events 9 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
11.4%
4/35 • Number of events 5 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
15.6%
7/45 • Number of events 9 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Infections and infestations
Bronchitis
|
6.5%
6/92 • Number of events 8 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
11.4%
4/35 • Number of events 5 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
9.1%
1/11 • Number of events 2 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
4.4%
2/45 • Number of events 3 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Injury, poisoning and procedural complications
Infusion-related reaction
|
13.0%
12/92 • Number of events 15 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
11.8%
4/34 • Number of events 4 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
11.4%
4/35 • Number of events 6 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
18.2%
2/11 • Number of events 3 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
13.3%
6/45 • Number of events 7 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.6%
7/92 • Number of events 7 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
5.7%
2/35 • Number of events 2 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
18.2%
2/11 • Number of events 2 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
8.9%
4/45 • Number of events 4 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Nervous system disorders
Headache
|
10.9%
10/92 • Number of events 15 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
8.8%
3/34 • Number of events 3 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
11.4%
4/35 • Number of events 7 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
8.3%
1/12 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
18.2%
2/11 • Number of events 4 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
11.1%
5/45 • Number of events 7 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Nervous system disorders
Dizziness
|
9.8%
9/92 • Number of events 11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
11.8%
4/34 • Number of events 4 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
5.7%
2/35 • Number of events 3 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
27.3%
3/11 • Number of events 4 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
15.6%
7/45 • Number of events 8 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Psychiatric disorders
Insomnia
|
7.6%
7/92 • Number of events 8 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
11.8%
4/34 • Number of events 5 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.9%
1/35 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/11 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
8.9%
4/45 • Number of events 5 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.7%
8/92 • Number of events 14 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
5.9%
2/34 • Number of events 3 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
11.4%
4/35 • Number of events 8 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/12 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
18.2%
2/11 • Number of events 3 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
8.9%
4/45 • Number of events 6 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.6%
7/92 • Number of events 9 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
0.00%
0/34 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
11.4%
4/35 • Number of events 6 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
16.7%
2/12 • Number of events 2 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
2.2%
1/45 • Number of events 1 • Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60