Phase I Dose Escalation of i.v. BI 836909 Monotherapy in... | NCT02514239 | Trialant
NCT02514239
Sponsor
Boehringer Ingelheim
Status
Completed
Last Update Posted
Feb 24, 2022Actual
Enrollment
43Actual
Phase
Phase 1
Conditions
Multiple Myeloma
Interventions
BI 836909
Countries
France
Germany
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT02514239
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1351.1
Secondary IDs
ID
Type
Description
Link
2014-004896-22
EudraCT Number
Brief Title
Phase I Dose Escalation of i.v. BI 836909 Monotherapy in Last Line Multiple Myeloma Patients
Official Title
An Open Label, Phase I, Dose Escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Doses of BI 836909 in Relapsed and/or Refractory Multiple Myeloma Patients
Acronym
Not provided
Organization
Boehringer IngelheimINDUSTRY
Status Module
Record Verification Date
Feb 2022
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 8, 2015Actual
Primary Completion Date
Jul 17, 2018Actual
Completion Date
Jul 2, 2020Actual
First Submitted Date
May 21, 2015
First Submission Date that Met QC Criteria
Jul 31, 2015
First Posted Date
Aug 3, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 29, 2021
Results First Submitted that Met QC Criteria
Jun 29, 2021
Results First Posted Date
Jul 22, 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
Feb 10, 2022
Last Update Posted Date
Feb 24, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Boehringer IngelheimINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The primary objective of this trial is to determine the maximum tolerated dose (MTD) of BI 836909 administered by continuous i.v. infusion in patients with relapsed and/or refractory multiple myeloma. If the MTD is not reached based on safety findings, a recommended dose for further development will be determined. This will depend on the safety data, pharmacokinetic/pharmacodynamics data and potentially preliminary efficacy data. Secondary objectives are to document the safety and tolerability of BI 836909, to perform pharmacokinetic and pharmacodynamic analyses and to evaluate relevant biological effects in terms of parameters of efficacy.
Detailed Description
Not provided
Conditions Module
Conditions
Multiple Myeloma
Keywords
Not provided
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
43Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Intravenous Infusion of BI 836909 (0.2 μg/d)
Experimental
Drug: BI 836909
Intravenous Infusion of BI 836909 (0.4 μg/d)
Experimental
Drug: BI 836909
Intravenous Infusion of BI 836909 (0.8 μg/d)
Experimental
Drug: BI 836909
Intravenous Infusion of BI 836909 (1.6 μg/d)
Experimental
Drug: BI 836909
Intravenous Infusion of BI 836909 (3.2 μg/d)
Experimental
Drug: BI 836909
Intravenous Infusion of BI 836909 (6.5 μg/d)
Experimental
Drug: BI 836909
Intravenous Infusion of BI 836909 (13 μg/d)
Experimental
Drug: BI 836909
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BI 836909
Drug
Intravenous Infusion of BI 836909.
Intravenous Infusion of BI 836909 (0.2 μg/d)
Intravenous Infusion of BI 836909 (0.4 μg/d)
Intravenous Infusion of BI 836909 (0.8 μg/d)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
The Maximum Tolerated Dose (MTD) of BI 836909
The Maximum tolerated dose (MTD) of BI 836909, which was defined as the highest dose of the dose level tested where ≤1 patient out of 6 developed a Dose-limiting toxicity (DLT). The MTD was defined based on DLTs observed during Cycle 1. However, all Adverse Events corresponding to the definition of a DLT (see below) were to be considered for confirming the MTD. A DLT was defined as any drug-related non-haematological Adverse Event of Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Grade 3 or higher.
Cycle 1, up to 6 weeks.
The Number of Patients With Dose-limiting Toxicities (DLTs)
The number of patients with Dose-limiting toxicities (DLTs) in cycle 1. A Dose-limiting toxicity was defined as any drug-related non-haematological Adverse Event of Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Grade 3 or higher.
Cycle 1, up to 6 weeks.
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With an Objective Response
Objective responses: Stringent complete response (sCR): CR + normal Free light chain (FLC) ratio and no clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR: negative immunofixation on serum and urine, disappearance of soft tissue plasmacytomas, and <5% plasma cells in bone marrow. Very good partial response (VGPR): serum and urine M protein detectable by immunofixation but not on electrophoresis or >90% reduction in serum M protein plus urine M protein level <100 mg/24h. PR: >50% reduction of serum and 24 h urinary M protein by >90% or to <200mg/24h. If unmeasurable, a >50% decrease in difference between involved and uninvolved FLC levels instead of M protein criteria. if FLC assay was not measurable, a >50% reduction in plasma cells was required instead of M protein, provided baseline bone marrow plasma cell was >30%. In addition to the listed criteria, a >50% reduction in the size of soft tissue plasmacytomas was also required, if present at baseline.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Patients with a documented diagnosis of relapsed and/or refractory multiple myeloma who progressed after at least two prior treatment regimens, including both proteasome inhibitor as well as an immune-modulatory drug at time of screening
must have measurable disease, defined by one or more of following at time of screening:
a serum M protein > 0.5 g/dl measured by serum protein electrophoresis
urinary M protein excretion > 200 mg/24 hours
serum free light chain (FLC) measurement > 10 mg/dl, provided that the serum FLC ratio is abnormal
Relapse or progression of disease with an indication for therapy as per investigator´s judgement at time of screening
ECOG Performance Status 0, 1 or 2 at time of screening
Age >= 18 years at time of screening
Written informed consent which is consistent with ICH_GCP guidelines and local legislation
Able to adhere to the study visit schedule e.g. ability to come to the clinic and to other protocol requirements
Indwelling central venous catheter or willingness to undergo intra venous central line placement.
Exclusion criteria:
Plasma cell leukemia
Extramedullary relapse of multiple myeloma
Known central nervous system involvement by multiple myeloma
Last anticancer treatment < 2 weeks prior to visit 1
Last treatment with a therapeutic antibody less than 6 weeks prior to visit 1
Prior allogeneic stem cell transplantation or solid organ transplantation
Autologous bone marrow transplantation < than 90 days at time of treatment start
Last corticosteroid < 2 weeks prior to visit 1 unless the dose is <= 10 mg/day prednisolone or equivalent
AST or ALT > 3 x upper limit of normal (CTCAE version 4.03 grade 2 or higher) at time of screening
Total conjugated bilirubin > 1.5 x upper limit of normal (CTCAE version 4.03 grade 2 or higher) at time of screening
Absolute neutrophil count < 1.0 x 109/L (without growth factor support) at time of screening
Platelets < 25 x 109/L (without transfusions) at time of screening
Calculated GFR < 30 mL/min (Cockcroft-Gault Formula) at time of screening
Clinical relevant concurrent medical disease or condition which according to the investigator's judgement would either compromise patient safety or interfere with the evaluation of the safety of the test drug, e.g. symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia requiring therapy at time of screening
clinically not controlled chronic or ongoing infectious disease requiring treatment at the time of enrolment or within the previous two weeks
Active hepatitis B or C, or laboratory evidence for a chronic infection with hepatitis B or C at time of screening; HIV infection at time of screening
Women of childbearing potential not using highly effective method of birth control during the trial until one year after the last dose. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year)when used consistently and correctly used such as implants, injectables, combined oral contraceptives, intrauterine devises (IUDs), sexual abstinence or vasectomised partner. Barrier methods of contraception are accepted if condom or occlusive cap is used together with spermicides (e.g. foam, gel). Female patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation/salpingectomy, or postmenopausal (12 months with no menses without an alternative medical cause
Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second medically acceptable method of contraception during the trial and for a minimum of 6 months after treatment
Pregnancy or breast feeding
Known or suspected active alcohol or drug abuse as per investigator's judgement
Treatment with another investigational drug within the past four weeks before start of therapy or concomitantly with this trial
Patients with known hypersensitivity to any component of the study drug
Patients with other malignancies within 5 years at time of screening (except basal cell or squamous cell carcinoma of the skin or carcinoma in situ treated with curative therapy)
Known autoimmune diseases requiring systemic treatment in past 5 years and interfering with evaluation of study drug
Pre-existing disorders of the central nervous system
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Recruitment Details
This was an open-label, non-randomised, phase I, dose escalation trial in patients with relapsed and/or refractory multiple myeloma. The first 4 dose levels (0.2, 0.4,0.8, and 1.6 Microgram Per Day (μg/d)) were tested in single patient cohorts. Dose levels ≥3.2 μg/d (3.2, 6.5, 13, 25, 50, 100, 200, 400, and 800 μg/d) were to be tested in a 3+3 design. Once the Maximum tolerated dose (MTD) was determined, up to 6 additional patients were to be treated at the MTD or at the recommended dose.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)
Intravenous infusion of BI 836909 (overall in the 4 lowest dose cohorts 0.2, 0.4, 0.8, 1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
FG001
Intravenous Infusion of BI 836909 (3.2 μg/d)
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
FG002
Intravenous Infusion of BI 836909 (6.5 μg/d)
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
FG003
Intravenous Infusion of BI 836909 (13 μg/d)
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
FG004
Intravenous Infusion of BI 836909 (25 μg/d)
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
FG005
Intravenous Infusion of BI 836909 (50 μg/d)
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
FG006
Intravenous Infusion of BI 836909 (100 μg/d)
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
FG007
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
FG008
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
FG009
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0005 subjects
FG0014 subjects
FG0023 subjects
FG0033 subjects
FG0043 subjects
FG0055 subjects
FG0064 subjects
FG0073 subjects
FG00810 subjects
FG0093 subjects
Treated
FG0005 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG004
COMPLETED
10 cycles completed
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
NOT COMPLETED
FG0005 subjects
FG0014 subjects
FG0022 subjects
FG0033 subjects
FG004
Type
Comment
Reasons
Refused to continue trial medication
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Treated set (TS): all patients who were administered trial medication.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)
Intravenous infusion of BI 836909 (overall in the 4 lowest dose cohorts 0.2, 0.4, 0.8, 1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
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
The Maximum Tolerated Dose (MTD) of BI 836909
The Maximum tolerated dose (MTD) of BI 836909, which was defined as the highest dose of the dose level tested where ≤1 patient out of 6 developed a Dose-limiting toxicity (DLT). The MTD was defined based on DLTs observed during Cycle 1. However, all Adverse Events corresponding to the definition of a DLT (see below) were to be considered for confirming the MTD. A DLT was defined as any drug-related non-haematological Adverse Event of Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Grade 3 or higher.
MTD evaluation set (MTDS): all patients who were administered trial medication and who were not replaced for the Maximum tolerated dose (MTD) determination.
Posted
Number
Microgram Per Day (μg/d)
Cycle 1, up to 6 weeks.
ID
Title
Description
OG000
Intravenous Infusion of BI 836909 (Total Dose Escalation)
BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles. The first 4 dose levels (0.2, 0.4,0.8, and 1.6 Microgram Per Day (μg/d)) were tested in single patient cohorts. Dose levels ≥3.2 μg/d (3.2, 6.5, 13, 25, 50, 100, 200, 400, and 800 μg/d) were tested in a 3+3 design.
Adverse Events Module
Frequency Threshold
5
Time Frame
Adverse Events collected from start of treatment till the last day of treatment + 30 Residual Effect Period, up to 436 days. All-cause Mortality collected from start of treatment till the last follow up visit, up to 113 weeks.
Description
Treated set (TS): all patients who were administered trial medication.
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
Intravenous Infusion of BI 836909 (0.2 μg/d)
Intravenous infusion of BI 836909 (0.2 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
On-treatment: From start of treatment till end of trial (EOT) visit, up to 61 weeks. Extended follow-up: From start of treatment till the last extended follow-up visit which was scheduled at 12 months after end of treatment, up to 113 weeks.
Duration of Objective Response - on Treatment
For patients with objective response, the duration of response was calculated from the time of first recorded achievement of a response (sCR, CR, PR, or VGPR) until documented progression or death. The Kaplan-Meier method was used to calculate the estimates.
From start of treatment till end of trial (EOT) visit, up to 61 weeks.
Duration of Objective Response - Including Extended Follow up Visits
For patients with objective response, the duration of response was calculated from the time of first recorded achievement of a response (sCR, CR, PR, or VGPR) until documented progression or death. The Kaplan-Meier method was used to calculate the estimates.
From start of treatment till the last extended follow-up visit which is scheduled at 12 months after end of treatment, up to 113 weeks.
Number of Participants With a Minimal Residual Disease (MRD) Response
Minimal residual disease (MRD) response was defined as <1 tumour cell within 10000 normal cells in bone marrow. MRD was determined using Fluorescence-activated cell sorting (FACS) analysis.
On-treatment: From start of treatment till end of trial (EOT) visit, up to 61 weeks. Follow-up: From start of treatment till the last extended follow-up visit which was scheduled at 12 months after end of treatment, up to 113 weeks.
Duration of Minimal Residual Disease (MRD) Response - on Treatment
Duration of MRD response was calculated from the time of first recorded achievement of a MRD response to documented progression or death. The Kaplan-Meier method was used to calculate the estimates.
From start of treatment till end of trial (EOT) visit, up to 61 weeks.
Duration of Minimal Residual Disease (MRD) Response - Including Extended Follow up Visits
Duration of MRD response was calculated from the time of first recorded achievement of a MRD response to documented progression or death. The Kaplan-Meier method was used to calculate the estimates.
From start of treatment till the last extended follow-up visit which was scheduled at 12 months after end of treatment, up to 113 weeks.
Progression-free Survival (PFS) - on Treatment
PFS was defined as time from first treatment with BI 836909 till disease progression or death. Progression was defined according to International Myeloma Working Group (IMWG 2006) response criteria as an increase >25% from lowest response value in any of the following parameters: -Serum M protein (absolute increase had to be >0.5 gram/ deciliters (dL)) -Urine M protein (absolute increase had to be >200 milligram (mg)/24 hour) -Only in patients without measurable serum and urine M protein levels The difference between involved and uninvolved FLC levels. Absolute increase had to be >10 mg/dL -Bone marrow plasma cell percentage; absolute percentage had to be >10% -Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas -Development of hypercalcaemia (corrected serum calcium >11.5 mg/dL or 2.65 Millimole/Liter) that was attributed solely to the plasma cell proliferative disorder.
From start of treatment till end of trial (EOT) visit, up to 61 weeks.
Progression-free Survival (PFS) - Including Extended Follow up Visits
PFS was defined as time from first treatment with BI 836909 till disease progression or death. Progression was defined according to International Myeloma Working Group (IMWG 2006) response criteria as an increase >25% from lowest response value in any of the following parameters: -Serum M protein (absolute increase had to be >0.5 gram/ deciliters (dL)) -Urine M protein (absolute increase had to be >200 milligram (mg)/24 hour) -Only in patients without measurable serum and urine M protein levels The difference between involved and uninvolved FLC levels. Absolute increase had to be >10 mg/dL -Bone marrow plasma cell percentage; absolute percentage had to be >10% -Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas -Development of hypercalcaemia (corrected serum calcium >11.5 mg/dL or 2.65 Millimole/Liter) that was attributed solely to the plasma cell proliferative disorder
From start of treatment till the last extended follow-up visit which was scheduled at 12 months after end of treatment, up to 113 weeks.
Serum Concentration at Steady State of BI 836909 (Css)
Serum concentration at steady state of BI 836909 (Css).
Pharmacokinetic samples were collected at 48:00 hours (h):minutes (min), 168:00, 336:00, 504:00 and 671:50 h after the start of infusion of BI 836909 of the first cycle.
Nantes
44000
France
INS Universitaire du Cancer
Toulouse
31059
France
Universitätsklinikum Ulm
Ulm
89081
Germany
Universitätsklinikum Würzburg
Würzburg
97080
Germany
3 subjects
FG0055 subjects
FG0064 subjects
FG0073 subjects
FG00810 subjects
FG0093 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
FG0090 subjects
3 subjects
FG0054 subjects
FG0064 subjects
FG0073 subjects
FG0088 subjects
FG0093 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
Dose-limiting toxicity (DLT)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0092 subjects
Not treated
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Other Adverse Events
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0071 subjects
FG0082 subjects
FG0090 subjects
Progressive disease
FG0003 subjects
FG0013 subjects
FG0022 subjects
FG0032 subjects
FG0043 subjects
FG0053 subjects
FG0064 subjects
FG0072 subjects
FG0085 subjects
FG0090 subjects
BG001
Intravenous Infusion of BI 836909 (3.2 μg/d)
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
BG002
Intravenous Infusion of BI 836909 (6.5 μg/d)
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
BG003
Intravenous Infusion of BI 836909 (13 μg/d)
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
BG004
Intravenous Infusion of BI 836909 (25 μg/d)
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
BG005
Intravenous Infusion of BI 836909 (50 μg/d)
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
BG006
Intravenous Infusion of BI 836909 (100 μg/d)
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
BG007
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
BG008
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
BG009
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
BG010
Total
Total of all reporting groups
5
BG0013
BG0023
BG0033
BG0043
BG0055
BG0064
BG0073
BG00810
BG0093
BG01042
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00058.6± 12.3
BG00167.7± 2.5
BG00263.0± 9.8
BG00369.3± 6.1
BG00467.0± 7.5
BG00561.6± 4.6
BG00662.5± 7.8
BG00762.7± 14.5
BG00857.7± 12.2
BG00971.3± 8.6
BG01062.6± 9.9
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0012
BG0020
BG0031
BG0041
BG0053
BG0060
BG0071
BG0083
BG0093
BG01015
Male
BG0004
BG0011
BG0023
BG0032
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
Asian
BG0000
BG0010
BG0020
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0010
BG0020
BG0030
BG004
White
BG0003
BG0011
BG0023
BG0032
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0002
BG0012
BG0020
BG0031
BG004
Units
Counts
Participants
OG00034
Title
Denominators
Categories
Title
Measurements
OG000400
Primary
The Number of Patients With Dose-limiting Toxicities (DLTs)
The number of patients with Dose-limiting toxicities (DLTs) in cycle 1. A Dose-limiting toxicity was defined as any drug-related non-haematological Adverse Event of Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Grade 3 or higher.
MTD evaluation set (MTDS): all patients who were administered trial medication and who were not replaced for the Maximum tolerated dose (MTD) determination.
Posted
Number
Participants
Cycle 1, up to 6 weeks.
ID
Title
Description
OG000
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)
Intravenous infusion of BI 836909 (overall in the 4 lowest dose cohorts 0.2, 0.4, 0.8, 1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG001
Intravenous Infusion of BI 836909 (3.2 μg/d)
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG002
Intravenous Infusion of BI 836909 (6.5 μg/d)
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG003
Intravenous Infusion of BI 836909 (13 μg/d)
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG004
Intravenous Infusion of BI 836909 (25 μg/d)
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG005
Intravenous Infusion of BI 836909 (50 μg/d)
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG006
Intravenous Infusion of BI 836909 (100 μg/d)
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG007
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG008
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG009
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Number of Participants With an Objective Response
Objective responses: Stringent complete response (sCR): CR + normal Free light chain (FLC) ratio and no clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR: negative immunofixation on serum and urine, disappearance of soft tissue plasmacytomas, and <5% plasma cells in bone marrow. Very good partial response (VGPR): serum and urine M protein detectable by immunofixation but not on electrophoresis or >90% reduction in serum M protein plus urine M protein level <100 mg/24h. PR: >50% reduction of serum and 24 h urinary M protein by >90% or to <200mg/24h. If unmeasurable, a >50% decrease in difference between involved and uninvolved FLC levels instead of M protein criteria. if FLC assay was not measurable, a >50% reduction in plasma cells was required instead of M protein, provided baseline bone marrow plasma cell was >30%. In addition to the listed criteria, a >50% reduction in the size of soft tissue plasmacytomas was also required, if present at baseline.
Treated set (TS): all patients who were administered trial medication.
Posted
Count of Participants
Participants
On-treatment: From start of treatment till end of trial (EOT) visit, up to 61 weeks. Extended follow-up: From start of treatment till the last extended follow-up visit which was scheduled at 12 months after end of treatment, up to 113 weeks.
ID
Title
Description
OG000
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)
Intravenous infusion of BI 836909 (overall in the 4 lowest dose cohorts 0.2, 0.4, 0.8, 1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG001
Intravenous Infusion of BI 836909 (3.2 μg/d)
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG002
Intravenous Infusion of BI 836909 (6.5 μg/d)
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG003
Intravenous Infusion of BI 836909 (13 μg/d)
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG004
Intravenous Infusion of BI 836909 (25 μg/d)
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG005
Intravenous Infusion of BI 836909 (50 μg/d)
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG006
Intravenous Infusion of BI 836909 (100 μg/d)
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG007
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG008
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG009
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Units
Counts
Participants
OG0005
OG0013
OG0023
OG003
Title
Denominators
Categories
On treatment
Title
Measurements
Stringent complete response (sCR)
OG0000
OG0010
OG0020
OG003
Secondary
Duration of Objective Response - on Treatment
For patients with objective response, the duration of response was calculated from the time of first recorded achievement of a response (sCR, CR, PR, or VGPR) until documented progression or death. The Kaplan-Meier method was used to calculate the estimates.
All patients who were administered trial medication and showed an objective response.
Posted
Median
Inter-Quartile Range
Months
From start of treatment till end of trial (EOT) visit, up to 61 weeks.
ID
Title
Description
OG000
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)
Intravenous infusion of BI 836909 (overall in the 4 lowest dose cohorts 0.2, 0.4, 0.8, 1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG001
Intravenous Infusion of BI 836909 (3.2 μg/d)
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG002
Intravenous Infusion of BI 836909 (6.5 μg/d)
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG003
Intravenous Infusion of BI 836909 (13 μg/d)
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG004
Intravenous Infusion of BI 836909 (25 μg/d)
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG005
Intravenous Infusion of BI 836909 (50 μg/d)
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG006
Intravenous Infusion of BI 836909 (100 μg/d)
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG007
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG008
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG009
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Units
Counts
Participants
OG0000
OG0010
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG002NA(NA to NA)Insufficient number of participants with events.
OG005NA(NA to NA)Insufficient number of participants with events.
OG006NA
Secondary
Duration of Objective Response - Including Extended Follow up Visits
For patients with objective response, the duration of response was calculated from the time of first recorded achievement of a response (sCR, CR, PR, or VGPR) until documented progression or death. The Kaplan-Meier method was used to calculate the estimates.
All patients who were administered trial medication and showed an objective response.
Posted
Median
Inter-Quartile Range
Months
From start of treatment till the last extended follow-up visit which is scheduled at 12 months after end of treatment, up to 113 weeks.
ID
Title
Description
OG000
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)
Intravenous infusion of BI 836909 (overall in the 4 lowest dose cohorts 0.2, 0.4, 0.8, 1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG001
Intravenous Infusion of BI 836909 (3.2 μg/d)
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG002
Intravenous Infusion of BI 836909 (6.5 μg/d)
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG003
Intravenous Infusion of BI 836909 (13 μg/d)
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG004
Intravenous Infusion of BI 836909 (25 μg/d)
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG005
Intravenous Infusion of BI 836909 (50 μg/d)
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG006
Intravenous Infusion of BI 836909 (100 μg/d)
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG007
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG008
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG009
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Units
Counts
Participants
OG0000
OG0010
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG002NA(NA to NA)Insufficient number of participants with events.
OG005NA(NA to NA)Insufficient number of participants with events.
OG006NA
Secondary
Number of Participants With a Minimal Residual Disease (MRD) Response
Minimal residual disease (MRD) response was defined as <1 tumour cell within 10000 normal cells in bone marrow. MRD was determined using Fluorescence-activated cell sorting (FACS) analysis.
Treated set (TS): all patients who were administered trial medication.
Posted
Count of Participants
Participants
On-treatment: From start of treatment till end of trial (EOT) visit, up to 61 weeks. Follow-up: From start of treatment till the last extended follow-up visit which was scheduled at 12 months after end of treatment, up to 113 weeks.
ID
Title
Description
OG000
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)
Intravenous infusion of BI 836909 (overall in the 4 lowest dose cohorts 0.2, 0.4, 0.8, 1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG001
Intravenous Infusion of BI 836909 (3.2 μg/d)
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG002
Intravenous Infusion of BI 836909 (6.5 μg/d)
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG003
Intravenous Infusion of BI 836909 (13 μg/d)
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG004
Intravenous Infusion of BI 836909 (25 μg/d)
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG005
Intravenous Infusion of BI 836909 (50 μg/d)
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG006
Intravenous Infusion of BI 836909 (100 μg/d)
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG007
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG008
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG009
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Units
Counts
Participants
OG0005
OG0013
OG0023
OG003
Title
Denominators
Categories
On treatment
Title
Measurements
OG0000
OG0010
OG0021
OG003
Secondary
Duration of Minimal Residual Disease (MRD) Response - on Treatment
Duration of MRD response was calculated from the time of first recorded achievement of a MRD response to documented progression or death. The Kaplan-Meier method was used to calculate the estimates.
All patients who were administered trial medication and showed a Minimal residual disease (MRD) response.
Posted
Median
Inter-Quartile Range
Months
From start of treatment till end of trial (EOT) visit, up to 61 weeks.
ID
Title
Description
OG000
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)
Intravenous infusion of BI 836909 (overall in the 4 lowest dose cohorts 0.2, 0.4, 0.8, 1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG001
Intravenous Infusion of BI 836909 (3.2 μg/d)
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG002
Intravenous Infusion of BI 836909 (6.5 μg/d)
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG003
Intravenous Infusion of BI 836909 (13 μg/d)
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG004
Intravenous Infusion of BI 836909 (25 μg/d)
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG005
Intravenous Infusion of BI 836909 (50 μg/d)
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG006
Intravenous Infusion of BI 836909 (100 μg/d)
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG007
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG008
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG009
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Units
Counts
Participants
OG0000
OG0010
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG002NA(NA to NA)Insufficient number of participants with events.
OG007NA(NA to NA)Insufficient number of participants with events.
OG008NA
Secondary
Duration of Minimal Residual Disease (MRD) Response - Including Extended Follow up Visits
Duration of MRD response was calculated from the time of first recorded achievement of a MRD response to documented progression or death. The Kaplan-Meier method was used to calculate the estimates.
All patients who were administered trial medication and showed a Minimal residual disease (MRD) response.
Posted
Median
Inter-Quartile Range
Months
From start of treatment till the last extended follow-up visit which was scheduled at 12 months after end of treatment, up to 113 weeks.
ID
Title
Description
OG000
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)
Intravenous infusion of BI 836909 (overall in the 4 lowest dose cohorts 0.2, 0.4, 0.8, 1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG001
Intravenous Infusion of BI 836909 (3.2 μg/d)
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG002
Intravenous Infusion of BI 836909 (6.5 μg/d)
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG003
Intravenous Infusion of BI 836909 (13 μg/d)
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG004
Intravenous Infusion of BI 836909 (25 μg/d)
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG005
Intravenous Infusion of BI 836909 (50 μg/d)
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG006
Intravenous Infusion of BI 836909 (100 μg/d)
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG007
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG008
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG009
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Units
Counts
Participants
OG0000
OG0010
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG002NA(NA to NA)Insufficient number of participants with events.
OG007NA(NA to NA)Insufficient number of participants with events.
OG00820.70
Secondary
Progression-free Survival (PFS) - on Treatment
PFS was defined as time from first treatment with BI 836909 till disease progression or death. Progression was defined according to International Myeloma Working Group (IMWG 2006) response criteria as an increase >25% from lowest response value in any of the following parameters: -Serum M protein (absolute increase had to be >0.5 gram/ deciliters (dL)) -Urine M protein (absolute increase had to be >200 milligram (mg)/24 hour) -Only in patients without measurable serum and urine M protein levels The difference between involved and uninvolved FLC levels. Absolute increase had to be >10 mg/dL -Bone marrow plasma cell percentage; absolute percentage had to be >10% -Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas -Development of hypercalcaemia (corrected serum calcium >11.5 mg/dL or 2.65 Millimole/Liter) that was attributed solely to the plasma cell proliferative disorder.
Treated set (TS): all patients who were administered trial medication.
Posted
Median
Inter-Quartile Range
Months
From start of treatment till end of trial (EOT) visit, up to 61 weeks.
ID
Title
Description
OG000
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)
Intravenous infusion of BI 836909 (overall in the 4 lowest dose cohorts 0.2, 0.4, 0.8, 1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG001
Intravenous Infusion of BI 836909 (3.2 μg/d)
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG002
Intravenous Infusion of BI 836909 (6.5 μg/d)
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG003
Intravenous Infusion of BI 836909 (13 μg/d)
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG004
Intravenous Infusion of BI 836909 (25 μg/d)
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG005
Intravenous Infusion of BI 836909 (50 μg/d)
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG006
Intravenous Infusion of BI 836909 (100 μg/d)
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG007
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG008
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG009
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Units
Counts
Participants
OG0005
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
OG001NA(NA to NA)Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
OG002
Secondary
Progression-free Survival (PFS) - Including Extended Follow up Visits
PFS was defined as time from first treatment with BI 836909 till disease progression or death. Progression was defined according to International Myeloma Working Group (IMWG 2006) response criteria as an increase >25% from lowest response value in any of the following parameters: -Serum M protein (absolute increase had to be >0.5 gram/ deciliters (dL)) -Urine M protein (absolute increase had to be >200 milligram (mg)/24 hour) -Only in patients without measurable serum and urine M protein levels The difference between involved and uninvolved FLC levels. Absolute increase had to be >10 mg/dL -Bone marrow plasma cell percentage; absolute percentage had to be >10% -Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas -Development of hypercalcaemia (corrected serum calcium >11.5 mg/dL or 2.65 Millimole/Liter) that was attributed solely to the plasma cell proliferative disorder
Treated set (TS): all patients who were administered trial medication.
Posted
Median
Inter-Quartile Range
Months
From start of treatment till the last extended follow-up visit which was scheduled at 12 months after end of treatment, up to 113 weeks.
ID
Title
Description
OG000
Intravenous Infusion of BI 836909 (Overall in the 4 Lowest Dose Cohorts 0.2, 0.4, 0.8, 1.6 μg/d)
Intravenous infusion of BI 836909 (overall in the 4 lowest dose cohorts 0.2, 0.4, 0.8, 1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG001
Intravenous Infusion of BI 836909 (3.2 μg/d)
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG002
Intravenous Infusion of BI 836909 (6.5 μg/d)
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG003
Intravenous Infusion of BI 836909 (13 μg/d)
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG004
Intravenous Infusion of BI 836909 (25 μg/d)
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG005
Intravenous Infusion of BI 836909 (50 μg/d)
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG006
Intravenous Infusion of BI 836909 (100 μg/d)
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG007
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG008
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG009
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Units
Counts
Participants
OG0005
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
OG001NA(NA to NA)Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
OG002
Secondary
Serum Concentration at Steady State of BI 836909 (Css)
Serum concentration at steady state of BI 836909 (Css).
PK Analysis Set (PKS): all evaluable patients in the treated set which provide at least one evaluable observation for at least one PK endpoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
picogram/milliliter (pg/mL)
Pharmacokinetic samples were collected at 48:00 hours (h):minutes (min), 168:00, 336:00, 504:00 and 671:50 h after the start of infusion of BI 836909 of the first cycle.
ID
Title
Description
OG000
Intravenous Infusion of BI 836909 (0.2 μg/d)
Intravenous infusion of BI 836909 (0.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG001
Intravenous Infusion of BI 836909 (0.4 μg/d)
Intravenous infusion of BI 836909 (0.4 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG002
Intravenous Infusion of BI 836909 (0.8 μg/d)
Intravenous infusion of BI 836909 (0.8 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG003
Intravenous Infusion of BI 836909 (1.6 μg/d)
Intravenous infusion of BI 836909 (1.6 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG004
Intravenous Infusion of BI 836909 (3.2 μg/d)
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG005
Intravenous Infusion of BI 836909 (6.5 μg/d)
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG006
Intravenous Infusion of BI 836909 (13 μg/d)
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles
OG007
Intravenous Infusion of BI 836909 (25 μg/d)
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG008
Intravenous Infusion of BI 836909 (50 μg/d)
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG009
Intravenous Infusion of BI 836909 (100 μg/d)
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG010
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG011
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
OG012
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
Units
Counts
Participants
OG0001
OG0011
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA± NAGeometric Mean and Geometric Coefficient of Variation could not be calculated because the serum concentrations of BI 836909 were below limit of quantitation (BLQ) for 0.2 ug/day.
OG00186.5± NAGeometric Coefficient of Variation could not be calculated because of the limited sample size.
OG002
0
1
1
1
1
1
EG001
Intravenous Infusion of BI 836909 (0.4 μg/d)
Intravenous infusion of BI 836909 (0.4 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
0
1
0
1
1
1
EG002
Intravenous Infusion of BI 836909 (0.8 μg/d)
Intravenous infusion of BI 836909 (0.8 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
0
2
1
2
1
2
EG003
Intravenous Infusion of BI 836909 (1.6 μg/d)
Intravenous infusion of BI 836909 (1.6 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
0
1
0
1
1
1
EG004
Intravenous Infusion of BI 836909 (3.2 μg/d)
Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
0
3
1
3
3
3
EG005
Intravenous Infusion of BI 836909 (6.5 μg/d)
Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
0
3
3
3
3
3
EG006
Intravenous Infusion of BI 836909 (13 μg/d)
Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
0
3
1
3
3
3
EG007
Intravenous Infusion of BI 836909 (25 μg/d)
Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
0
3
1
3
3
3
EG008
Intravenous Infusion of BI 836909 (50 μg/d)
Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
1
5
3
5
5
5
EG009
Intravenous Infusion of BI 836909 (100 μg/d)
Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
0
4
2
4
4
4
EG010
Intravenous Infusion of BI 836909 (200 μg/d)
Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
0
3
3
3
3
3
EG011
Intravenous Infusion of BI 836909 (400 μg/d)
Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
1
10
8
10
10
10
EG012
Intravenous Infusion of BI 836909 (800 μg/d)
Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.
0
3
3
3
2
3
EG013
Intravenous Infusion of BI 836909 (Total Dose Escalation)
BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles. The first 4 dose levels (0.2, 0.4,0.8, and 1.6 Microgram Per Day (μg/d)) were tested in single patient cohorts. Dose levels ≥3.2 μg/d (3.2, 6.5, 13, 25, 50, 100, 200, 400, and 800 μg/d) were tested in a 3+3 design.
2
42
27
42
40
42
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Disease progression
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Generalised oedema
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Pyrexia
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Bile duct obstruction
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Hepatic failure
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Cytokine release syndrome
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected3 at risk
EG0113 affected10 at risk
EG0121 affected3 at risk
EG0135 affected42 at risk
Aspergillus infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Catheter site infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Device related infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Influenza
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Lung infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Pneumonia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0041 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0112 affected10 at risk
EG0121 affected3 at risk
EG0135 affected42 at risk
Vascular device infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0071 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0101 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0134 affected42 at risk
Malnutrition
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Peripheral motor neuropathy
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0121 affected3 at risk
EG0131 affected42 at risk
Polyneuropathy
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Spinal cord compression
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Renal failure
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0043 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0082 affected5 at risk
EG0092 affected4 at risk
EG0101 affected3 at risk
EG0115 affected10 at risk
EG0121 affected3 at risk
EG01315 affected42 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0061 affected3 at risk
EG0071 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0135 affected42 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Cardiomyopathy
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Sinus bradycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Eustachian tube dysfunction
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0121 affected3 at risk
EG0131 affected42 at risk
Vertigo positional
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Hyperthyroidism
Endocrine disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0071 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Hypothyroidism
Endocrine disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0071 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Lacrimation increased
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Abdominal rigidity
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Constipation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0031 affected1 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0100 affected3 at risk
EG0113 affected10 at risk
EG0120 affected3 at risk
EG0136 affected42 at risk
Dry mouth
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Gastric disorder
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0121 affected3 at risk
EG0131 affected42 at risk
Gingival bleeding
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Haemorrhoids
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0121 affected3 at risk
EG0131 affected42 at risk
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0091 affected4 at risk
EG0101 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0135 affected42 at risk
Tongue discomfort
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Tooth demineralisation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0031 affected1 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0101 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0135 affected42 at risk
Adverse drug reaction
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0121 affected3 at risk
EG0131 affected42 at risk
Asthenia
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0133 affected42 at risk
Chills
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0112 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Fatigue
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0031 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0071 affected3 at risk
EG0082 affected5 at risk
EG0090 affected4 at risk
EG0101 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0136 affected42 at risk
Hyperthermia
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0112 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Oedema
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Oedema peripheral
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0031 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0121 affected3 at risk
EG0134 affected42 at risk
Pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Pyrexia
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0031 affected1 at risk
EG0041 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0092 affected4 at risk
EG0102 affected3 at risk
EG0113 affected10 at risk
EG0120 affected3 at risk
EG01311 affected42 at risk
Swelling
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Cytokine release syndrome
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0092 affected4 at risk
EG0101 affected3 at risk
EG0117 affected10 at risk
EG0122 affected3 at risk
EG01312 affected42 at risk
Hypersensitivity
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Hypogammaglobulinaemia
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Seasonal allergy
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Bacteraemia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Bronchitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Candida infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Catheter site infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Device related infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0101 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0133 affected42 at risk
Herpes simplex
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Herpes zoster
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Influenza
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0133 affected42 at risk
Nasopharyngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0061 affected3 at risk
EG0071 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0133 affected42 at risk
Onychomycosis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Otitis media
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0112 affected10 at risk
EG0121 affected3 at risk
EG0133 affected42 at risk
Parainfluenzae virus infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Pneumonia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Pneumonia fungal
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0121 affected3 at risk
EG0131 affected42 at risk
Pulpitis dental
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Respiratory syncytial virus infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0101 affected3 at risk
EG0112 affected10 at risk
EG0120 affected3 at risk
EG0134 affected42 at risk
Respiratory tract infection viral
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0121 affected3 at risk
EG0132 affected42 at risk
Rhinitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0133 affected42 at risk
Rhinovirus infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Sinusitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0112 affected10 at risk
EG0120 affected3 at risk
EG0133 affected42 at risk
Staphylococcal infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected3 at risk
EG0112 affected10 at risk
EG0120 affected3 at risk
EG0133 affected42 at risk
Tinea pedis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Tonsillitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0121 affected3 at risk
EG0131 affected42 at risk
Urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0041 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0101 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0134 affected42 at risk
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0133 affected42 at risk
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Sternal fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Alanine aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Blood alkaline phosphatase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Blood bilirubin increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Blood creatinine increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0101 affected3 at risk
EG0112 affected10 at risk
EG0120 affected3 at risk
EG0136 affected42 at risk
Blood glucose increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Blood immunoglobulin G decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected3 at risk
EG0112 affected10 at risk
EG0120 affected3 at risk
EG0133 affected42 at risk
Blood immunoglobulin G increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Blood lactate dehydrogenase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Blood phosphorus increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Blood urea increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Blood uric acid decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Blood uric acid increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
C-reactive protein increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0071 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0100 affected3 at risk
EG0112 affected10 at risk
EG0120 affected3 at risk
EG0134 affected42 at risk
Eosinophil count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Fibrin D dimer increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0071 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Gamma-glutamyltransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0052 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0134 affected42 at risk
Haemoglobin decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Lymphocyte count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0001 affected1 at risk
EG0011 affected1 at risk
EG0021 affected2 at risk
EG0030 affected1 at risk
EG0041 affected3 at risk
EG0052 affected3 at risk
EG0061 affected3 at risk
EG0072 affected3 at risk
EG0083 affected5 at risk
EG0092 affected4 at risk
EG0102 affected3 at risk
EG0115 affected10 at risk
EG0122 affected3 at risk
EG01323 affected42 at risk
Monocyte count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0121 affected3 at risk
EG0132 affected42 at risk
Neutrophil count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0072 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0101 affected3 at risk
EG0115 affected10 at risk
EG0121 affected3 at risk
EG01310 affected42 at risk
Neutrophil count increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0101 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Platelet count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0092 affected4 at risk
EG0101 affected3 at risk
EG0113 affected10 at risk
EG0122 affected3 at risk
EG01310 affected42 at risk
Red blood cell count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0121 affected3 at risk
EG0131 affected42 at risk
Weight decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0121 affected3 at risk
EG0132 affected42 at risk
White blood cell count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0041 affected3 at risk
EG0051 affected3 at risk
EG0061 affected3 at risk
EG0072 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0101 affected3 at risk
EG0116 affected10 at risk
EG0122 affected3 at risk
EG01316 affected42 at risk
pH urine increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0102 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0134 affected42 at risk
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0114 affected10 at risk
EG0122 affected3 at risk
EG0137 affected42 at risk
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0133 affected42 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0071 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0112 affected10 at risk
EG0121 affected3 at risk
EG0136 affected42 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0031 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0133 affected42 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0071 affected3 at risk
EG0082 affected5 at risk
EG0091 affected4 at risk
EG0101 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0137 affected42 at risk
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0112 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0113 affected10 at risk
EG0120 affected3 at risk
EG0135 affected42 at risk
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0112 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0031 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0112 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Dizziness
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Dysgeusia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0121 affected3 at risk
EG0131 affected42 at risk
Headache
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0062 affected3 at risk
EG0070 affected3 at risk
EG0083 affected5 at risk
EG0091 affected4 at risk
EG0100 affected3 at risk
EG0115 affected10 at risk
EG0122 affected3 at risk
EG01313 affected42 at risk
Post herpetic neuralgia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Sciatica
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Syncope
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Tongue paralysis
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Irritability
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Restlessness
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Sleep disorder
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Glycosuria
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Renal failure
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Urinary retention
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0100 affected3 at risk
EG0113 affected10 at risk
EG0120 affected3 at risk
EG0134 affected42 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0101 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0133 affected42 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0112 affected10 at risk
EG0121 affected3 at risk
EG0135 affected42 at risk
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0061 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Eczema
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0101 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0091 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0091 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0132 affected42 at risk
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0051 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0101 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Haematoma
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Hypertension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0121 affected3 at risk
EG0132 affected42 at risk
Hypotension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0041 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0121 affected3 at risk
EG0132 affected42 at risk
Varicose vein
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0080 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0111 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
Venous thrombosis limb
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected2 at risk
EG0030 affected1 at risk
EG0040 affected3 at risk
EG0050 affected3 at risk
EG0060 affected3 at risk
EG0070 affected3 at risk
EG0081 affected5 at risk
EG0090 affected4 at risk
EG0100 affected3 at risk
EG0110 affected10 at risk
EG0120 affected3 at risk
EG0131 affected42 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
D014652
Vascular Diseases
D002318
Cardiovascular Diseases
D010265
Paraproteinemias
D001796
Blood Protein Disorders
D006402
Hematologic Diseases
D006425
Hemic and Lymphatic Diseases
D006474
Hemorrhagic Disorders
D008232
Lymphoproliferative Disorders
D007160
Immunoproliferative Disorders
D007154
Immune System Diseases
2
BG0052
BG0064
BG0072
BG0087
BG0090
BG01027
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
2
BG0053
BG0062
BG0072
BG0088
BG0092
BG01028
0
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
1
BG0052
BG0062
BG0071
BG0082
BG0091
BG01014
3
OG0043
OG0053
OG0063
OG0073
OG0086
OG0093
0
OG0040
OG0050
OG0060
OG0070
OG0081
OG0092
3
OG0043
OG0055
OG0064
OG0073
OG00810
OG0093
0
OG0040
OG0050
OG0060
OG0071
OG0085
OG0090
Complete response (CR)
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0061
OG0070
OG0080
OG0090
Very good partial response (VGPR)
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0081
OG0091
Partial response (PR)
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
OG0070
OG0081
OG0091
No response (stable disease or disease progression)
OG0005
OG0013
OG0022
OG0033
OG0043
OG0054
OG0063
OG0072
OG0083
OG0091
On treatment + extended follow-up visits (follow-up
Title
Measurements
Stringent complete response (sCR)
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0085
OG0090
Complete response (CR)
OG0000
OG0010
OG0021
OG0030
OG004
Very good partial response (VGPR)
OG0000
OG0010
OG0020
OG0030
OG004
Partial response (PR)
OG0000
OG0010
OG0020
OG0030
OG004
No response (stable disease or disease progression)
OG0005
OG0013
OG0022
OG0033
OG004
0
OG0040
OG0051
OG0061
OG0071
OG0087
OG0092
(NA to NA)
Insufficient number of participants with events.
OG007NA(NA to NA)Insufficient number of participants with events.
OG008NA(4.63 to NA)Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
OG009NA(NA to NA)Insufficient number of participants with events.
0
OG0040
OG0051
OG0061
OG0071
OG0087
OG0092
(NA to NA)
Insufficient number of participants with events.
OG007NA(NA to NA)Insufficient number of participants with events.
OG00823.62(4.63 to 24.18)
OG009NA(NA to NA)Insufficient number of participants with events.
3
OG0043
OG0055
OG0064
OG0073
OG00810
OG0093
0
OG0040
OG0050
OG0060
OG0071
OG0086
OG0090
On treatment + extended follow-up visits (follow-up)
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0071
OG0086
OG0090
0
OG0040
OG0050
OG0060
OG0071
OG0086
OG0090
(9.00 to NA)
Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
0
OG0040
OG0050
OG0060
OG0071
OG0086
OG0090
(9.00 to 22.77)
3
OG0043
OG0055
OG0064
OG0073
OG00810
OG0093
NA
(NA to NA)
Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
OG003NA(NA to NA)Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
OG004NA(NA to NA)Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
OG005NA(NA to NA)Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
OG006NA(NA to NA)Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
OG007NA(NA to NA)Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
OG0085.55(0.95 to NA)Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
OG009NA(NA to NA)Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
3
OG0043
OG0055
OG0064
OG0073
OG00810
OG0093
NA
(NA to NA)
Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
OG003NA(NA to NA)Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
OG004NA(NA to NA)Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
OG005NA(NA to NA)Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
OG006NA(NA to NA)Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
OG007NA(NA to NA)Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
OG0087.74(0.95 to 24.41)
OG009NA(NA to NA)Estimates for median and/or IQR are missing because the largest observation was censored and the estimation was restricted to the largest event time observed in this clinical trial.
1
OG0043
OG0053
OG0063
OG0073
OG0085
OG0094
OG0103
OG0119
OG0122
90.8
± 41.1
OG003184± NAGeometric Coefficient of Variation could not be calculated because of the limited sample size.