A Phase 1/2a Study of Human Anti-CD 38 Antibody MOR03087... | NCT01421186 | Trialant
NCT01421186
Sponsor
MorphoSys AG
Status
Completed
Last Update Posted
Nov 16, 2021Actual
Enrollment
91Actual
Phase
Phase 1Phase 2
Conditions
Multiple Myeloma
Interventions
MOR03087 phase 1 dose escalation
MOR03087
Dexamethasone
Pomalidomide
Lenalidomide
Countries
Austria
Germany
Protocol Section
Identification Module
NCT ID
NCT01421186
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MOR202C101
Secondary IDs
ID
Type
Description
Link
DRKS00003145
Registry Identifier
German Clinical Trail Register
Brief Title
A Phase 1/2a Study of Human Anti-CD 38 Antibody MOR03087 (MOR202) in Relapsed/Refractory Multiple Myeloma
Official Title
A Phase 1/2a, Open-Label, Multicentre, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of the Human Anti-CD 38 Antibody MOR03087 as Monotherapy and in Combination With Standard Therapy in Subjects With Relapsed/Refractory Multiple Myeloma
Acronym
Not provided
Organization
MorphoSys AGINDUSTRY
Status Module
Record Verification Date
Jul 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 2011Actual
Primary Completion Date
Aug 2020Actual
Completion Date
Aug 2020Actual
First Submitted Date
Jul 29, 2011
First Submission Date that Met QC Criteria
Aug 19, 2011
First Posted Date
Aug 22, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 20, 2021
Results First Submitted that Met QC Criteria
Sep 30, 2021
Results First Posted Date
Oct 28, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 12, 2021
Last Update Posted Date
Nov 16, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
MorphoSys AGINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is an open-label, multicentre, dose escalation study to characterize the safety and preliminary efficacy of the human anti-CD38 antibody MOR03087 (MOR202), in adult subjects with relapsed/refractory multiple myeloma, as monotherapy and in adult subjects with relapsed/refractory multiple myeloma in combination with standard therapy.
Detailed Description
The study enrolled patients aged 18 years or older with relapsed or refractory multiple myeloma and Karnofsky performance status of 60% or higher. Patients were assigned to the different treatment regimens with MOR202 ranging between 0·01 mg/kg and 16 mg/kg in a 3 + 3 design. Dose-escalation and expansion was done either with MOR202 intravenous infusions alone (MOR202 q2w [twice a week] and q1w [weekly] groups) or in combination with dexamethasone (MOR202 with dexamethasone group), with dexamethasone plus pomalidomide (MOR202 with dexamethasone plus pomalidomide group) or plus lenalidomide (MOR202 with dexamethasone plus lenalidomide group). Primary endpoints were safety, MOR202 maximum tolerated dose (or recommended dose) and regimen, and immunogenicity.
Conditions Module
Conditions
Multiple Myeloma
Keywords
Multiple Myeloma
MOR03087 (MOR202)
Lenalidomide
Pomalidomide
CD38
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
91Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 1 dose escalation
Experimental
Part A: MOR03087 dose escalation; biweekly treatment
Part B: MOR03087 dose escalation; weekly treatment
Part C: MOR03087 dose escalation (weekly treatment) + dexamethasone
Part D: MOR03087 weekly treatment in combination with pomalidomide + dexamethasone
Part E: MOR03087 weekly treatment in combination with lenalidomide + dexamethasone
For all parts, patients will be treated until disease progression (PD) or until a maximum of 3 years after first treatment.
Drug: MOR03087 phase 1 dose escalation
Drug: Dexamethasone
Drug: Pomalidomide
Drug: Lenalidomide
Phase 2a confirmatory cohorts
Experimental
Confirmatory cohorts of MOR03087 monotherapy (plus or minus dexamethasone), in combination with pomalidomide plus dexamethasone, and in combination with lenalidomide plus dexamethasone.
Following completion of Parts A, B, and C (dose escalation of MOR03087 biweekly and weekly schedules), the Maximum Tolerated Dose (MTD) or recommended dose and dosing regimen will be confirmed in a minimum of 6 subjects.
Following completion of Parts D (dose escalation of MOR03087 in combination with pomalidomide + dexamethasone) and E (dose escalation of MOR03087 in combination with lenalidomide + dexamethasone), the MTD and/or recommended dose in each part will be confirmed in a minimum of 6 subjects.
For all parts, patients will be treated until PD or until a maximum of 3 years after first treatment.
Drug: MOR03087
Drug: Dexamethasone
Drug: Pomalidomide
Drug: Lenalidomide
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MOR03087 phase 1 dose escalation
Drug
Treatment cycles will be 28 days. Initial MOR03087 doses will be 0.01 mg/kg in part A, 4 mg/kg in parts B and C and 8 mg/kg in parts D and E; in all parts MOR03087 doses will be escalated to a maximum of 16 mg/kg. In part A, patients will receive a biweekly intravenous infusion of MOR03087 which will be administered on days 1 and 15 of the cycle. In parts B to E patients will receive a weekly intravenous infusion of MOR03087 which will be administered on days 1, 8, 15, and 22 of the cycle.
In all parts a loading dose of MOR03087 will be additionally administered on day 4 of cycle 1.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Determination of Maximum Tolerated Dose and / or Recommended Dose and Dosing Regimen of MOR03087
as monotherapy
in combination with dexamethasone
in combination with pomalidomide + dexamethasone
in combination with lenalidomide + dexamethasone
First cycle of treatment
Number of Participants Who Develop Anti-MOR03087 Antibodies
Number of participants who develop anti-MOR03087 antibodies, a measure of immunogenicity
during treatment period, maximum 3 years after 1st dose
Secondary Outcomes
Measure
Description
Time Frame
Overall Response Rate
number (#) of patients responding (# stringent complete response + # complete response + # very good partial response + # partial response)
maximum 3 years after 1st dose
Time to Progression
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female subjects 18 years and older
Relapsed or refractory multiple myeloma defined as:
Parts A, B and C:
(i) Failure of at least 2 previous therapies which must have included an immunomodulatory agent and a proteasome inhibitor (either together or part of different therapies) (ii) All subjects must have documented progression during or after their last prior therapy for multiple myeloma
Part D:
(i) At least 2 previous therapies including lenalidomide and a proteasome inhibitor (ii) All subjects must have documented progression during or within 60 days after their last prior therapy for multiple myeloma
Part E:
(i) Received at least one previous therapy (ii) All subjects must have documented progression during or after their last prior therapy for multiple myeloma
Presence of serum M-protein ≥ 0.5 g per 100 mL (≥ 5 g/L) and / or urine M-protein ≥ 200 mg per 24-hour period
Absolute neutrophil count (ANC) ≥ 1,000 / mm3
Haemoglobin ≥ 8 g/dL
Ability to comply with all study related procedures, medication use and evaluations
Exclusion Criteria:
Primary refractory multiple myeloma
History of significant cerebrovascular disease or sensory or motor neuropathy of toxicity grade 3 or higher
Treatment with systemic investigational agent within 28 days prior to first study treatment
Solitary plasmacytoma or plasma cell leukaemia
Previous allogenic stem cell transplant (SCT)
Prior therapy with other monoclonal antibodies targeting the CD38 antigen or prior therapy with other IgG monoclonal antibodies within 3 months prior to first study treatment, or IgM monoclonal antibodies within 1 month prior to first study treatment
Active systemic infection
Systemic disease preventing study treatment
Multiple myeloma with central nervous system (CNS) involvement
Previous treatment with cytotoxic chemotherapy or large field radiotherapy or other myeloma specific therapy within 28 days prior to first study treatment (radiation to a single site as concurrent therapy is allowed)
Significant uncontrolled cardiovascular disease or cardiac insufficiency (New York Heart Association [NYHA] classes III, IV)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
AKH (Allgemeines Krankenhaus der Stadt Wien), Abteilung für Klinische Onkologie, Universitätsklinik für Innere Medizin I
Raab MS, Engelhardt M, Blank A, Goldschmidt H, Agis H, Blau IW, Einsele H, Ferstl B, Schub N, Rollig C, Weisel K, Winderlich M, Griese J, Hartle S, Weirather J, Jarutat T, Peschel C, Chatterjee M. MOR202, a novel anti-CD38 monoclonal antibody, in patients with relapsed or refractory multiple myeloma: a first-in-human, multicentre, phase 1-2a trial. Lancet Haematol. 2020 May;7(5):e381-e394. doi: 10.1016/S2352-3026(19)30249-2. Epub 2020 Mar 11.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A: MOR03087 Biweekly Dose Escalation
Treatment cycle 28 days, MOR03087 doses applied day 1 & 15, initial 0.01 mg/kg, max 16 mg/kg
FG001
Part B: MOR03087 Weekly Dose Escalation
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jul 17, 2017
Jul 20, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Phase 1 dose escalation
MOR03087
Drug
MOR03087 will be administered according to the Maximum Tolerated Dose (MTD) or recommended dose and dosing regimen for MOR03087 from parts A-E of the phase I dose escalation. The biweekly MOR03087 regimen as described in part A; the weekly regimen as described for parts B-E.
Phase 2a confirmatory cohorts
Dexamethasone
Drug
Dexamethasone will be administered to patients orally; 40 mg (≤ 75 years old) or 20 mg (> 75 years old) on days 1, 8, 15, and 22 of the 28-day cycle. An additional dose will be administered in cycle 1 on day 4.
Phase 1 dose escalation
Phase 2a confirmatory cohorts
Pomalidomide
Drug
Pomalidomide will be administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
Phase 1 dose escalation
Phase 2a confirmatory cohorts
Lenalidomide
Drug
Lenalidomide will be administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
Pharmacokinetics: Cmax - Maximum Observed Serum Concentration for MOR202
PK analysis for MOR202 4, 8 and 16 mg/kg IV once weekly dose groups only, since serum concentrations of MOR202 were substantially affected by target mediated drug disposition effects for remaining dose groups
up to 7 days after last MOR202 dose
Pharmacokinetics: AUC Cycle 1+2 - Area Under the Time/Concentration Curve for MOR202
PK analysis for MOR202 4, 8 and 16 mg/kg IV once weekly dose groups only, since serum concentrations of MOR202 were substantially affected by target mediated drug disposition effects for remaining dose groups
Sektion für Stammzell- und Immuntherapie, II. Medizinischen Klinik,
Kiel
24105
Germany
Klinikum rechts der Isar/ Studien / III. Med. Klinik
Munich
81675
Germany
Medizinische Klinik II, Abt. Hämatologie, Onkologie,
Tübingen
7206
Germany
Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II, Studienambulanz für Hämatologie/Onkologie und Infektiologie
Würzburg
97080
Germany
Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg
FG002
Part C: MOR03087 Plus Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old)
FG003
Part D: MOR03087 Plus Pomalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
FG004
Part E: MOR03087 Plus Lenalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old).
Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
FG00031 subjects
FG0014 subjects
FG00218 subjects
FG00321 subjects
FG00417 subjects
COMPLETED
FG00031 subjects
FG0014 subjects
FG00218 subjects
FG00321 subjects
FG00417 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: MOR03087 Biweekly Dose Escalation
Treatment cycle 28 days, MOR03087 doses applied day 1 & 15, initial 0.01 mg/kg, max 16 mg/kg
BG001
Part B: MOR03087 Weekly Dose Escalation
Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg
BG002
Part C: MOR03087 Plus Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old)
BG003
Part D: MOR03087 Plus Pomalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
BG004
Part E: MOR03087 Plus Lenalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old).
Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00031
BG0014
BG00218
BG00321
BG00417
BG00591
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00012
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Austria
Title
Measurements
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Determination of Maximum Tolerated Dose and / or Recommended Dose and Dosing Regimen of MOR03087
as monotherapy
in combination with dexamethasone
in combination with pomalidomide + dexamethasone
in combination with lenalidomide + dexamethasone
Posted
Number
mg/kg
First cycle of treatment
ID
Title
Description
OG000
Part A: MOR03087 Biweekly Dose Escalation
Treatment cycle 28 days, MOR03087 doses applied day 1 & 15, initial 0.01 mg/kg, max 16 mg/kg
OG001
Part B: MOR03087 Weekly Dose Escalation
Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg
OG002
Part C: MOR03087 Plus Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old)
OG003
Part D: MOR03087 Plus Pomalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
OG004
Part E: MOR03087 Plus Lenalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old).
Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
Units
Counts
Participants
OG00031
OG0014
OG00218
OG003
Title
Denominators
Categories
Title
Measurements
OG00016
OG00116
OG00216
OG003
Primary
Number of Participants Who Develop Anti-MOR03087 Antibodies
Number of participants who develop anti-MOR03087 antibodies, a measure of immunogenicity
all patients with available data
Posted
Count of Participants
Participants
during treatment period, maximum 3 years after 1st dose
ID
Title
Description
OG000
Part A: MOR03087 Biweekly Dose Escalation
Treatment cycle 28 days, MOR03087 doses applied day 1 & 15, initial 0.01 mg/kg, max 16 mg/kg
OG001
Part B: MOR03087 Weekly Dose Escalation
Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg
OG002
Part C: MOR03087 Plus Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old)
OG003
Part D: MOR03087 Plus Pomalidomide + Dexamethasone
Secondary
Overall Response Rate
number (#) of patients responding (# stringent complete response + # complete response + # very good partial response + # partial response)
Posted
Count of Participants
Participants
maximum 3 years after 1st dose
ID
Title
Description
OG000
Part A: MOR03087 Biweekly Dose Escalation
Treatment cycle 28 days, MOR03087 doses applied day 1 & 15, initial 0.01 mg/kg, max 16 mg/kg
OG001
Part B: MOR03087 Weekly Dose Escalation
Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg
OG002
Part C: MOR03087 Plus Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old)
OG003
Part D: MOR03087 Plus Pomalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
Secondary
Time to Progression
Time to Progression (Kaplan Meier estimate)
safety population
Posted
Median
95% Confidence Interval
months
patients were observed for up to 36 months
ID
Title
Description
OG000
Part A: MOR03087 Biweekly Dose Escalation
Treatment cycle 28 days, MOR03087 doses applied day 1 & 15, initial 0.01 mg/kg, max 16 mg/kg
OG001
Part B: MOR03087 Weekly Dose Escalation
Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg
OG002
Part C: MOR03087 Plus Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old)
OG003
Part D: MOR03087 Plus Pomalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
Treatment cycle 28 days, MOR03087 doses applied day 1 & 15, initial 0.01 mg/kg, max 16 mg/kg
OG001
Part B: MOR03087 Weekly Dose Escalation
Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg
OG002
Part C: MOR03087 Plus Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old)
OG003
Part D: MOR03087 Plus Pomalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
Secondary
Duration of Response
Duration of response (Kaplan Meier estimates)
Of the total 91 patients, 26 obtained a response: 5 in part C, 10 in part D and 11 in part E. Duration of response was calculated only in these patients.
Posted
Median
95% Confidence Interval
months
patients were observed up to 36 months
ID
Title
Description
OG000
Part C: MOR03087 Plus Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old)
OG001
Part D: MOR03087 Plus Pomalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
OG002
Part E: MOR03087 Plus Lenalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old).
Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
Secondary
Pharmacokinetics: Cmax - Maximum Observed Serum Concentration for MOR202
PK analysis for MOR202 4, 8 and 16 mg/kg IV once weekly dose groups only, since serum concentrations of MOR202 were substantially affected by target mediated drug disposition effects for remaining dose groups
Pharmakokinetics was analysed on all available data on patients receiving 4mg/kg weekly, 8mg/kg weekly and 16 mg/kg weekly irrespective in which part the patients were treated.
Posted
Mean
Standard Deviation
µg/mL
up to 7 days after last MOR202 dose
ID
Title
Description
OG000
4 mg/kg QW
Dosing at 4 mg/kg IV once weekly (incl. one add. dose on Cycle 1 Day 4)
OG001
8 mg/kg QW
Dosing at 8 mg/kg IV once weekly (incl. one add. dose on Cycle 1 Day 4)
OG002
16 mg/kg QW
Dosing at 16 mg/kg IV once weekly (incl. one add. dose on Cycle 1 Day 4)
Units
Counts
Participants
Secondary
Pharmacokinetics: AUC Cycle 1+2 - Area Under the Time/Concentration Curve for MOR202
PK analysis for MOR202 4, 8 and 16 mg/kg IV once weekly dose groups only, since serum concentrations of MOR202 were substantially affected by target mediated drug disposition effects for remaining dose groups
Pharmakokinetics was analysed on all available data on patients receiving 4mg/kg weekly, 8mg/kg weekly and 16 mg/kg weekly irrespective in which part the patients were treated.
Posted
Mean
Standard Deviation
mg*days/L
56 days
ID
Title
Description
OG000
4 mg/kg QW
Dosing at 4 mg/kg IV once weekly (incl. one add. dose on Cycle 1 Day 4)
OG001
8 mg/kg QW
Dosing at 8 mg/kg IV once weekly (incl. one add. dose on Cycle 1 Day 4)
OG002
16 mg/kg QW
Dosing at 16 mg/kg IV once weekly (incl. one add. dose on Cycle 1 Day 4)
Units
Counts
Participants
Time Frame
during the entire period of trial drug application and beyond until end of study visit/up to 30 days after last administration of study drug. Patients stayed on study drug up to 3 years.
Description
regular investigator assessment and laboratory testing
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part A: MOR03087 Biweekly Dose Escalation
Treatment cycle 28 days, MOR03087 doses applied day 1 & 15, initial 0.01 mg/kg, max 16 mg/kg
2
31
13
31
31
31
EG001
Part B: MOR03087 Weekly Dose Escalation
Treatment cycle 28 days, MOR03087 doses applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, Initial MOR03087 dose 4 mg/kg, max 16 mg/kg For all parts, patients will be treated until PD or until a maximum of 3 years after first treatment.
MOR03087: MOR03087 will be administered according to the Maximum Tolerated Dose (MTD) or recommended dose and dosing regimen for MOR03087 from parts A-E of the phase I dose escalation. The biweekly MOR03087 regimen as described in part A; the weekly regimen as described for parts B-E..
0
4
4
4
4
4
EG002
Part C: MOR03087 Plus Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old)
0
18
7
18
18
18
EG003
Part D: MOR03087 Plus Pomalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
1
21
20
21
21
21
EG004
Part E: MOR03087 Plus Lenalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 4 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old).
Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
4
17
14
17
17
17
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG0039 events6 affected21 at risk
EG0041 events1 affected17 at risk
Respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0022 events2 affected18 at risk
EG003
Pneumonia influenzal
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Pulmonary Sepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Skin Infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Infusion-related reaction
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0004 events4 affected31 at risk
EG0014 events4 affected4 at risk
EG0020 affected18 at risk
EG003
Plasma Cell Myeloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0004 events4 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Breast Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0012 events1 affected4 at risk
EG0020 affected18 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0013 events1 affected4 at risk
EG0020 events0 affected18 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 affected4 at risk
EG0020 events0 affected18 at risk
EG003
Acute Kidney Injury
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Dental Caries
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 events0 affected18 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 events0 affected18 at risk
EG003
Radiculopathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 events0 affected18 at risk
EG003
Atrial Flutter
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Cardiac Failure
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Cardiovascular Disorder
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Myocardial Infarction
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0011 events1 affected4 at risk
EG0020 affected18 at risk
EG003
Sinus Tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Cheast Pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Osteonecrosis of Jaw
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Pseudarthrosis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Spinal Stenosis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Renal Failure
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Renal Impairment
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Mouth Haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Spinal Cord Compression
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Transient Ischaemic Attack
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Type 2 Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Febrile Neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Infectious Pleural Effusion
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 events0 affected4 at risk
EG0020 affected18 at risk
EG003
Bacterial Infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Meningoencephalitis Bacterial
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Parainfluenza Virus Infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0011 events1 affected4 at risk
EG0020 affected18 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Respiratory Syncytal Virus Infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Varicella Zoster Virus Infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Femoral Neck Fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Sternal Fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Eccrine Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Malignant Melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Pancreatic Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Squamous Cell Carcinoma of the Skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0020 affected18 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG00013 events8 affected31 at risk
EG0017 events4 affected4 at risk
EG00228 events8 affected18 at risk
EG00391 events17 affected21 at risk
EG00455 events15 affected17 at risk
Nasopharyngitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0008 events6 affected31 at risk
EG0011 events1 affected4 at risk
EG00212 events9 affected18 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0004 events4 affected31 at risk
EG00112 events3 affected4 at risk
EG00226 events8 affected18 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0009 events5 affected31 at risk
EG0014 events2 affected4 at risk
EG00225 events8 affected18 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG00020 events13 affected31 at risk
EG0013 events1 affected4 at risk
EG00210 events7 affected18 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected31 at risk
EG0011 events1 affected4 at risk
EG0029 events6 affected18 at risk
EG003
C-reactive proteine increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0012 events1 affected4 at risk
EG0028 events3 affected18 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected18 at risk
EG003
Lipase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG00214 events3 affected18 at risk
EG003
Amylase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected4 at risk
EG0025 events2 affected18 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Blood creatinine phosphokinase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0004 events2 affected31 at risk
EG0010 events0 affected4 at risk
EG0022 events1 affected18 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected4 at risk
EG00210 events2 affected18 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected31 at risk
EG0011 events1 affected4 at risk
EG0027 events6 affected18 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected4 at risk
EG00212 events2 affected18 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0005 events4 affected31 at risk
EG0010 events0 affected4 at risk
EG0023 events2 affected18 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0013 events1 affected4 at risk
EG0023 events3 affected18 at risk
EG003
Infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected18 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected4 at risk
EG0023 events1 affected18 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0002 events1 affected31 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected18 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Systematic Assessment
EG00012 events11 affected31 at risk
EG0010 events0 affected4 at risk
EG00214 events6 affected18 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0006 events5 affected31 at risk
EG0010 events0 affected4 at risk
EG0024 events3 affected18 at risk
EG003
Disease progression
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0011 events1 affected4 at risk
EG0022 events2 affected18 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.0
Systematic Assessment
EG0004 events3 affected31 at risk
EG0010 events0 affected4 at risk
EG0028 events2 affected18 at risk
EG003
Asthenia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0023 events3 affected18 at risk
EG003
Diarrhea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0009 events7 affected31 at risk
EG0011 events1 affected4 at risk
EG0025 events4 affected18 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0005 events4 affected31 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected18 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected18 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG00014 events10 affected31 at risk
EG0010 events0 affected4 at risk
EG0023 events2 affected18 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected18 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0006 events4 affected31 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected18 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0022 events1 affected18 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected18 at risk
EG003
Plasma cell myeloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG00016 events16 affected31 at risk
EG0012 events2 affected4 at risk
EG00212 events12 affected18 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0007 events5 affected31 at risk
EG0011 events1 affected4 at risk
EG0022 events2 affected18 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected4 at risk
EG0022 events1 affected18 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0004 events3 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected18 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0014 events1 affected4 at risk
EG0023 events2 affected18 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected18 at risk
EG003
Muscle spasm
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected31 at risk
EG0010 events0 affected4 at risk
EG0025 events2 affected18 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected4 at risk
EG0027 events6 affected18 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected4 at risk
EG0024 events3 affected18 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected31 at risk
EG0010 events0 affected4 at risk
EG0025 events4 affected18 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0004 events3 affected31 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected18 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0005 events5 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0008 events6 affected31 at risk
EG0011 events1 affected4 at risk
EG0024 events3 affected18 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected31 at risk
EG0013 events2 affected4 at risk
EG0023 events3 affected18 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0004 events4 affected31 at risk
EG0010 events0 affected4 at risk
EG0023 events3 affected18 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected4 at risk
EG0022 events1 affected18 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0008 events6 affected31 at risk
EG0010 events0 affected4 at risk
EG0028 events6 affected18 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0004 events3 affected31 at risk
EG0010 events0 affected4 at risk
EG0025 events3 affected18 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0003 events2 affected31 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0023 events2 affected18 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected4 at risk
EG0022 events1 affected18 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0004 events3 affected31 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected18 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected4 at risk
EG0023 events3 affected18 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0004 events4 affected31 at risk
EG0010 events0 affected4 at risk
EG0029 events3 affected18 at risk
EG003
Haematoma
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected4 at risk
EG0029 events3 affected18 at risk
EG003
Hypotension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected31 at risk
EG0010 events0 affected4 at risk
EG0023 events2 affected18 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0011 events1 affected4 at risk
EG00221 events6 affected18 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected31 at risk
EG0013 events2 affected4 at risk
EG0023 events3 affected18 at risk
EG003
Cataract
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected18 at risk
EG003
Blood urea increased
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Neutrophilia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Swelling
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected18 at risk
EG003
Impaired healing
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Hyperamylasaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Vitamin D Deficiency
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0023 events3 affected18 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected18 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Osteitis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected4 at risk
EG0022 events1 affected18 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected18 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0022 events1 affected18 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected4 at risk
EG0022 events1 affected18 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0023 events1 affected18 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0022 events1 affected18 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0024 events1 affected18 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0023 events1 affected18 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Eczema asteatotic
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Nail growth abnormal
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected18 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Hot flush
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Iliac artery stenosis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Varicous vein
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Restlessness
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected18 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0022 events1 affected18 at risk
EG003
Mood altered
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected18 at risk
EG003
Vision blurred
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Visual impairment
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected18 at risk
EG003
Diplopia
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected18 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected18 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected18 at risk
EG003
Supraventricular extrasystoles
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected18 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected18 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected18 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected18 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Dr Winrich Rauschning, Clinical Project Lead (external)
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old). Pomalidomide was administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
OG004
Part E: MOR03087 Plus Lenalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old).
Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
Units
Counts
Participants
OG00031
OG0014
OG00218
OG00321
OG00417
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG004
Part E: MOR03087 Plus Lenalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old).
Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
Units
Counts
Participants
OG00031
OG0014
OG00218
OG00321
OG00417
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0025
OG00310
OG00411
OG004
Part E: MOR03087 Plus Lenalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old).
Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
Units
Counts
Participants
OG00031
OG0014
OG00218
OG00321
OG00417
Title
Denominators
Categories
Title
Measurements
OG0001.1(1.0 to 1.4)
OG0012.1(0.7 to NA)Upper confidence limit could not be estimated due to low number of patients with an event.
OG0028.4(1.4 to 11.1)
OG00315.9(4.1 to 25.8)
OG00433.2(5.1 to NA)Upper confidence limit could not be estimated due to low number of patients with an event.
OG004
Part E: MOR03087 Plus Lenalidomide + Dexamethasone
Treatment cycle 28 days, iv MOR03087 and oral dexamethasone (DEX) applied day 1, 8, 15 & 22 plus extra dose on day 4 of cycle 1, initial MOR03087 dose 8 mg/kg, max 16 mg/kg. DEX dose 40 mg (≤ 75 years old) or 20 mg (> 75 years old).
Lenalidomide was administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
Units
Counts
Participants
OG00031
OG0014
OG00218
OG00321
OG00417
Title
Denominators
Categories
Title
Measurements
OG0001.1(1.0 to 1.4)
OG0012.1(0.7 to NA)Upper confidence limit could not be estimated due to low number of patients with an event.
OG0028.4(1.4 to 11.1)
OG00315.9(3.0 to 22.1)
OG00426.7(5.1 to NA)Upper confidence limit could not be estimated due to low number of patients with an event.
Units
Counts
Participants
OG0005
OG00110
OG00211
Title
Denominators
Categories
Title
Measurements
OG00016.7(1.9 to NA)Upper confidence limit could not be estimated due to low number of patients with an event.
OG00121.2(9.2 to NA)Upper confidence limit could not be estimated due to low number of patients with an event.
OG00232.2(4.2 to NA)Upper confidence limit could not be estimated due to low number of patients with an event.