PF-06863135 As Single Agent And In Combination With Immun... | NCT03269136 | Trialant
NCT03269136
Sponsor
Pfizer
Status
Completed
Last Update Posted
Mar 18, 2025Actual
Enrollment
101Actual
Phase
Phase 1
Conditions
Multiple Myeloma
Interventions
PF-06863135 monotherapy IV or SC
PF-06863135 + dexamethasone
PF-06863135 + lenalidomide
PF-06863135 + pomalidomide
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT03269136
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C1071001
Secondary IDs
ID
Type
Description
Link
2019-000822-24
EudraCT Number
Brief Title
PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma
Official Title
MAGNETISMM-1 A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY, PHARMACOKINETIC, PHARMACODYNAMIC AND CLINICAL ACTIVITY OF ELRANATAMAB (PF-06863135), A B-CELL MATURATION ANTIGEN (BCMA) - CD3 BISPECIFIC ANTIBODY, AS A SINGLE AGENT AND IN COMBINATION WITH IMMUNOMODULATORY AGENTS IN PATIENTS WITH RELAPSED/REFRACTORY ADVANCED MULTIPLE MYELOMA (MM)
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Mar 2025
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
Nov 29, 2017Actual
Primary Completion Date
Jan 19, 2024Actual
Completion Date
Jan 19, 2024Actual
First Submitted Date
Aug 16, 2017
First Submission Date that Met QC Criteria
Aug 29, 2017
First Posted Date
Aug 31, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Jan 8, 2025
Results First Submitted that Met QC Criteria
Mar 11, 2025
Results First Posted Date
Mar 18, 2025Actual
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
Mar 11, 2025
Last Update Posted Date
Mar 18, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
To assess the safety and tolerability at increasing dose levels of PF-06863135 in patients with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
Detailed Description
Study C1071001 is a Phase 1, open label, multi dose, multi center, dose escalation, safety, pharmacokinetic (PK) and pharmacodynamic study of PF-06863135 in adult patients with advanced multiple myeloma who have relapsed from or are refractory to standard therapy. This is a two part study; Part 1 will assess the safety and tolerability of increasing dose levels of PF-06863135 and Part 2 will evaluate safety and anti-myeloma activity of PF-06863135 at the RP2Ds determined in Part 1.
Conditions Module
Conditions
Multiple Myeloma
Keywords
Multiple Myeloma
relapse/ refractory multiple myeloma
bispecific antibody
bispecific
BCMA
BCMA- CD3 bispecific
Phase 1
PF-06863135
dexamethasone
lenalidomide
pomalidomide
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
101Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
PF-06863135
Experimental
BCMA-CD3 bispecific antibody
Drug: PF-06863135 monotherapy IV or SC
PF-06863135 + dexamethasone
Experimental
BCMA-CD3 bispecific antibody + dexamethasone
Drug: PF-06863135 + dexamethasone
PF-06863135 + lenalidomide
Experimental
BCMA-CD3 bispecific antibody + lenalidomide
Drug: PF-06863135 + lenalidomide
PF-06863135 + pomalidomide
Experimental
BCMA-CD3 bispecific antibody + pomalidomide
Drug: PF-06863135 + pomalidomide
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PF-06863135 monotherapy IV or SC
Drug
PF-06863135 will be administered intravenously or subcutaneously.
PF-06863135
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03
Hematological: Grade 4 neutropenia lasting >5 days; Febrile neutropenia <1000/mm^3 with a single temperature of >38.3 degree Celsius (C) or a sustained temperature of >=38 degree C for more than one hour; grade >=3 neutropenia with infection; grade 4 thrombocytopenia; grade 3 thrombocytopenia with >= Grade 2 bleeding. Non-hematological: grade 4 adverse events (AEs); Grade 3 AE lasting >=5 days despite optimal supportive care, with exception of AE attributed to cytokine release syndrome (CRS) event; grade 3 CRS, except those CRS that had a) not been maximally treated or b) improved to <=grade 1 within 48 hours; grade 4 CRS; confirmed drug-induced liver injury (DILI) meeting Hy's law criteria; grade 4 laboratory abnormalities deemed clinically significant by the investigator reported Grade 4 AE; clinically important or persistent toxicities that were not included in above criteria were also be considered a DLT following review by the investigators and the sponsor.
Cycle 1 (21 Days)
Part 2: Objective Response Rate (ORR) as Per International Myeloma Working Group (IMWG) Criteria
ORR per IMWG criteria: percentage of participants with best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). sCR: complete response plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates. 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/24 hr. PR: >=50% reduction of serum M-protein and reduction in 24 hrs urinary M-protein by >=90% or to <200 mg/24 hr. If serum and urine M-protein were unmeasurable, >=50% decrease in difference between involved and uninvolved FLC levels required in place of the M-protein criteria.
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34.3 months)
Secondary Outcomes
Measure
Description
Time Frame
Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03
AE: any untoward medical occurrence in clinical study participant, temporally associated with use of study intervention, whether or not considered related to intervention. TEAE: any event increasing in severity from baseline or event started during PF-06863135 therapy or within 30 days of last dose of drug. SAE: any untoward medical occurrence at any dose that resulted in either: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission via Pfizer product of infectious agent, pathogenic or non-pathogenic; or considered as important event. Treatment-related AE: AEs attributed to drug in participants who received drug. Relatedness was judged by investigator. NCI CTCAE v4.03, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. AEs included SAEs and all non-SAEs.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Relapsed/refractory multiple myeloma
Progressed or are intolerant of established therapies including proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody
Performance Status of 0- 1 ( Performance Score 2 is permitted only if due to underlying myeloma)
Adequate bone marrow, hematological, kidney and liver function
Resolved acute effects of any prior therapy to baseline severity
Not pregnant
Exclusion Criteria:
Recent history of other malignancies
History of active autoimmune disorders
Any form of primary immunodeficiency
Active and clinically significant bacterial, fungal, or viral infection
Evidence of active mucosal or internal bleeding
History of severe immune-mediated adverse event with prior immunomodulatory treatment
Major surgery within 4 weeks of study treatment start
Radiation therapy within 2 weeks of study treatment start
History of stem cell transplant (autologous or allogeneic) within 100 days prior to study enrollment
Donor Lymphocyte Infusion (DLI) within 30 days prior to study entry
Less than 30 days since last dose of antibody based therapies or less than 5 half-lives since last dose of previous therapy
Requirement for systemic immune suppressive medication except as permitted in the protocol
Current requirement for chronic blood product support
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
UCSD Medical Center - Encinitas
Encinitas
California
92024
United States
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Hospital)
Hibma JE, Irby D, Liu A, Elmeliegy M, King LE, Gifondorwa D, Jiang S, Poels KE, Soltantabar P, Lon HK, Shtylla B, Wang D, Williams JH, Nicholas T. Elranatamab Population Pharmacokinetics and Exposure-Response for Cytokine Release Syndrome in Patients with Relapsed or Refractory Multiple Myeloma. Clin Pharmacokinet. 2026 Jun 13. doi: 10.1007/s40262-026-01663-z. Online ahead of print.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
The following parts were planned for the study: Part 1 dose escalation included Part 1 monotherapy, Part 1.1 dose priming, Part 1C lenalidomide combination, Part 1D pomalidomide combination and Part 1E dexamethasone combination. Part 2 dose expansion included Part 2A monotherapy, Part 2C lenalidomide combination, Part 2D pomalidomide combination and Part 2E dexamethasone combination. Participants were not enrolled in Parts 1E, 2C, 2D and 2E and their data is not reported in the record.
Recruitment Details
A total of 101 participants (Part 1: 86 participants and Part 2: 15 participants) were enrolled in the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: PF-06863135 0.1 mcg/kg IV
Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Periods
Title
Milestones
Reasons Not Completed
Part 1: Dose Escalation
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Mar 29, 2023
Jan 8, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Greece
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
BCMA-CD3 bispecific antibody
PF-06863135 + dexamethasone
Drug
PF-06863135 will be administered intravenously or subcutaneously and dexamethasone orally.
PF-06863135 + dexamethasone
BCMA-CD3 bispecific antibody + dexamethasone
PF-06863135 + lenalidomide
Drug
PF-06863135 will be administered intravenously or subcutaneously and lenalidomide orally
PF-06863135 + lenalidomide
BCMA-CD3 bispecific antibody + lenalidomide
PF-06863135 + pomalidomide
Drug
PF-06863135 will be administered intravenously or subcutaneously and pomalidomide orally
PF-06863135 + pomalidomide
BCMA-CD3 bispecific antibody + pomalidomide
Part 2: Duration of Response (DOR) as Per IMWG Criteria
DOR per IMWG criteria:time from first documentation of objective tumor (OT)response to first documentation of OTprogression or to death due to any cause, whichever occurred first.sCR: CR plus normal FLC ratio & absence of clonal cells in bone marrow biopsy by immunohistochemistry;CR:Negative immunofixation on serum & urine & disappearance of any soft tissue plasmacytomas&<5% plasma cells in bone marrow aspirates.VGPR: serum & urine M-protein(Mp) detectable by immunofixation but not on electrophoresis or >=90% reduction in serum Mp plus urine Mp level <100 mg/24 hr. PR: >=50% reduction of serum Mp & reduction in 24 hrs urinary Mp by >=90% or to <200 mg/24 hr.If serum & urine Mp were unmeasurable, >=50% decrease in difference between involved & uninvolved FLC levels required in place of Mp criteria. Progression: appearance of local, regional or distant disease of same type after CR or progression of pre-existing lesions. It did not include second primary malignancies of unrelated types.
From the first documentation of objective tumor response to first documentation of objective tumor progression or new anti-cancer therapies or death, whichever occurred first, (maximum up to 34.3 months)
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 43.3 months)
Part 1: Number of Participants With Shifts From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters
Hematology parameters included: activated partial thromboplastin time prolonged, anemia, hemoglobin increased, international normalized ratio (INR) increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and, white blood cell decreased. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of hematology parameters are reported.
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 43.3 months)
Part 1: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters
Clinical chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia and hypophosphatemia. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of clinical chemistry parameters are reported.
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 43.3 months)
Part 1: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Urinalysis
Proteinuria was estimated in urinalysis. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of urinalysis parameters are reported.
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 43.3 months)
Part 1: ORR as Per IMWG Criteria
ORR per IMWG criteria: percentage of participants with best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). sCR: complete response plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates. 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/24 hr. PR: >=50% reduction of serum M-protein and reduction in 24 hrs urinary M-protein by >=90% or to <200 mg/24 hr. If serum and urine M-protein were unmeasurable, >=50% decrease in difference between involved and uninvolved FLC levels required in place of the M-protein criteria.
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 63.31 months)
Part 1: Time to Response (TTR) as Per IMWG Criteria
TTR: Defined for participants with confirmed objective response as time from first dose to first documentation of objective tumor response. sCR: complete response + normal FLC ratio & absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: Negative immunofixation on serum& urine & disappearance of soft tissue plasmacytomas & <5% plasma cells in bone marrow aspirates. VGPR: serum& urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein level <100 mg/24 hr. PR: >=50% reduction of serum M-protein& reduction in 24hrs urinary M-protein by >=90% or <200 mg/24hr. If serum & urine M-protein unmeasurable, >=50% decrease in difference between involved & uninvolved FLC levels required in place of M-protein criteria. Progression: Appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types.
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 63.31 months)
Part 1: Complete Response Rate (CRR) as Per IMWG Criteria
CRR: percentage of participants with complete response (sCR or CR). sCR: complete response plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates.
From the first dose of study treatment until the first documented sCR or CR or new anti-cancer therapies or death, whichever occurred first (maximum up to 63.31 months)
Part 1: DOR as Per IMWG Criteria
DOR per IMWG criteria:time from first documentation of objective tumor (OT)response to first documentation of OTprogression or to death due to any cause, whichever occurred first.sCR: CR plus normal FLC ratio & absence of clonal cells in bone marrow biopsy by immunohistochemistry;CR:Negative immunofixation on serum & urine & disappearance of any soft tissue plasmacytomas&<5% plasma cells in bone marrow aspirates.VGPR: serum & urine M-protein(Mp) detectable by immunofixation but not on electrophoresis or >=90% reduction in serum Mp plus urine Mp level <100 mg/24 hr. PR: >=50% reduction of serum Mp & reduction in 24 hrs urinary Mp by >=90% or to <200 mg/24 hr.If serum & urine Mp were unmeasurable, >=50% decrease in difference between involved & uninvolved FLC levels required in place of Mp criteria. Progression: appearance of local, regional or distant disease of same type after CR or progression of pre-existing lesions. It did not include second primary malignancies of unrelated types.
From the first documentation of objective tumor response to first documentation of objective tumor progression or new anti-cancer therapies or death, whichever occurred first, (maximum up to 63.31 months)
Part 1: Duration of Complete Response (DoCR) as Per IMWG Criteria
DoCR was defined for participants with confirmed complete response (sCR or CR) as the time from the first documentation of complete response to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. sCR: complete response plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates. Progression was defined as appearance of local, regional or distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types.
From the first documentation of complete response to the first documentation of tumor progression or death, whichever occurred first (maximum up to 63.31 months)
Part 1: Duration of Stable Disease (DOSD) as Per IMWG Criteria
DOSD per IMWG criteria: participants with confirmed stable disease (SD): time from first documentation (doc) of objective SD to first doc of objective tumor progression (P)/death by any cause, whichever occurred first. SD: not meeting criteria for CR,VGPR, PR, MR or PD. CR: Negative immunofixation on serum & urine &disappearance of any soft tissue plasmacytomas &<5% plasma cells in bone marrow aspirates. VGPR: serum & urine M-protein (Mp) detectable by immunofixation but not on electrophoresis or >=90% reduction in serum Mp plus urine Mp level <100 mg/24 hr. PR: >=50% reduction of serum Mp & reduction in 24 hours urinary Mp by >=90% or<200 mg/24 hr. If serum & urine Mp were unmeasurable, >=50% decrease in difference between involved & uninvolved FLC levels required in place of Mp criteria. Progression: appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types.
Time from the first documentation of objective stable disease to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first (maximum up to 63.31 months)
Part 1: Progression Free Survival (PFS) as Per IMWG Criteria
PFS as per IMWG criteria was the time from start date of study treatment to date of first documentation of progression, or death due to any cause. Progression was defined as the appearance of local, regional or distant disease of the same type after CR or progression of pre-existing lesions. It does not include second primary malignancies of unrelated types. CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates.
From start date of study treatment to date of first documentation of progression or death due to any cause, whichever occurred first (maximum up to 63.31 months)
Part 1: Overall Survival (OS)
OS was defined as the time from start date of study treatment to date of death due to any cause. OS for participants not known to had died were censored on the date of last known alive.
Time from start date of study treatment to date of death due to any cause or last-known-alive date, whichever occurred first (maximum up to 63.31 months)
Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria
MRD negativity rate: percentage of participants with negative MRD (assessed by central laboratory) per IMWG criteria at any time from date of first dose until first documentation of confirmed progression, death or start of new anticancer therapy, whichever occurred first. Progression was defined as appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types. MRD negativity was defined by two thresholds, 10^-5 and 10^-6.
Anytime from date of first dose until the first documentation of confirmed PD, death or start of new anticancer therapy, whichever occurred first (maximum up to 63.31 months)
Part 1: Maximum Observed Concentration (Cmax) of PF-06863135
Cmax of PF-06863135 was measured in this outcome measure. Total is free and bound drug in the body.
0 hours (h) on Day 1 of Cycle (C) 0; 0, 2 and 4h on Day 1 of C1 and C2
Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau)
Area under the concentration curve from time 0 to end of dosing interval (AUCtau) was measured in this outcome measure. Total is free and bound drug in the body.
0 hours (h) on Day 1 of Cycle (C) 0; 0, 2 and 4h on Day 1 of C1 and C2
Part 1C and Part 1D: Plasma Concentration of Lenalidomide and Pomalidomide
Plasma concentration of lenalidomide and pomalidomide was measured in this outcome measure.
Cycle 1 (0 hours post dose on Day 1, 8 and 15); Cycle 2 (0 hours on Day 15)
Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135
Number of participants with ADA and NAb against PF-06863135 were reported in this outcome measure. A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participant had >= 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a >= 4-folder dilution increase in titer from baseline in >= 1 post-treatment sample (treatment-boosted).
From first dose of the study treatment (Day 1) up to end of study treatment (maximum up to 63.31 months)
Part 1: Concentration of Soluble Cytokines in Serum
The concentration of Interleukin-2, Interleukin-6, Interferon-gamma and tumor necrosis factor-alpha were measured in this outcome measure. Cycle = C.
Part 1: C1 (0, 2, 4 & 8 hours [h] post dose on Day [D] 1, 24h post dose on D2, 72h post dose on D3); Part 1.1, 1C & 1D: C0 (0, 2, 4 & 8h post dose on D1, 24h post dose on D2); C1 (0, 2, 4 & 8h post dose on D1, 24h post dose on D2, 72h post dose on D3)
Part 2: Number of Participants With AEs, Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03
AE: any untoward medical occurrence in clinical study participant, temporally associated with use of study intervention, whether or not considered related to intervention. TEAE: any event increasing in severity from baseline or event started during PF-06863135 therapy or within 30 days of last dose of drug. SAE: any untoward medical occurrence at any dose that resulted in either: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission via Pfizer product of infectious agent, pathogenic or non-pathogenic; or considered as important event. Treatment-related AE: AEs attributed to drug in participants who received drug. Relatedness was judged by investigator. NCI CTCAE v4.03, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. AEs included SAEs and all non-SAEs.
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 32.3 months)
Part 2: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters
Hematology parameters included: activated partial thromboplastin time prolonged, anemia, hemoglobin increased, international normalized ratio (INR) increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and, white blood cell decreased. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of hematology parameters are reported.
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 32.3 months)
Part 2: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters
Clinical chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia and hypophosphatemia. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of clinical chemistry parameters are reported.
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 32.3 months)
Part 2: Number of Participants With Shifts From Grade <=2 to Grade 3 or 4 Post-Baseline in Urinalysis
Proteinuria was estimated in urinalysis. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of urinalysis parameters are reported.
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 32.3 months)
Part 2: CRR as Per IMWG Criteria
CRR: percentage of participants with complete response (sCR or CR). sCR: complete response plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates.
From the first dose of study treatment until the first documented sCR or CR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34.3 months)
Part 2: DoCR as Per IMWG Criteria
DoCR was defined for participants with confirmed complete response (sCR or CR) as the time from the first documentation of complete response to the first documentation of objective tumor progression or to death due to any cause, whichever occured first. sCR: complete response plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates. Progression was defined as appearance of local, regional or distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types.
From the first documentation of complete response to the first documentation of tumor progression or death, whichever occurred first (maximum up to 34.3 months)
Part 2: TTR as Per IMWG Criteria
TTR: Defined for participants with confirmed objective response as time from first dose to first documentation of objective tumor response. sCR: complete response + normal FLC ratio & absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: Negative immunofixation on serum& urine & disappearance of soft tissue plasmacytomas & <5% plasma cells in bone marrow aspirates. VGPR: serum& urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein level <100 mg/24 hr. PR: >=50% reduction of serum M-protein& reduction in 24hrs urinary M-protein by >=90% or <200 mg/24hr. If serum & urine M-protein unmeasurable, >=50% decrease in difference between involved & uninvolved FLC levels required in place of M-protein criteria. Progression: Appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types.
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34.3 months)
Part 2: DOSD as Per IMWG Criteria
DOSD per IMWG criteria: participants with confirmed stable disease (SD): time from first documentation (doc) of objective SD to first doc of objective tumor progression (P)/death by any cause, whichever occurred first. SD: not meeting criteria for CR,VGPR, PR, MR or PD. CR: Negative immunofixation on serum & urine &disappearance of any soft tissue plasmacytomas &<5% plasma cells in bone marrow aspirates. VGPR: serum & urine M-protein (Mp) detectable by immunofixation but not on electrophoresis or >=90% reduction in serum Mp plus urine Mp level <100 mg/24 hr. PR: >=50% reduction of serum Mp & reduction in 24 hours urinary Mp by >=90% or<200 mg/24 hr. If serum & urine Mp were unmeasurable, >=50% decrease in difference between involved & uninvolved FLC levels required in place of Mp criteria. Progression: appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types.
Time from the first documentation of objective stable disease to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first (maximum up to 34.3 months)
Part 2: PFS as Per IMWG Criteria
PFS as per IMWG criteria was the time from start date of study treatment to date of first documentation of progression, or death due to any cause. Progression was defined as the appearance of local, regional or distant disease of the same type after CR or progression of pre-existing lesions. It does not include second primary malignancies of unrelated types. CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates.
From start date of study treatment to date of first documentation of progression or death due to any cause, whichever occurred first (maximum up to 34.3 months)
Part 2: OS
OS was defined as the time from start date of study treatment to date of death due to any cause. OS for participants not known to had died were censored on the date of last known alive.
Time from start date of study treatment to date of death due to any cause or last-known-alive date, whichever occurred first (maximum up to 34.3 months)
Part 2: Percentage of Participants With Negative MRD After Treatment With PF-06863135 Using IMWG MRD Criteria
MRD negativity rate: percentage of participants with negative MRD (assessed by central laboratory) per IMWG criteria at any time from date of first dose until first documentation of confirmed progression, death or start of new anticancer therapy, whichever occurred first. Progression was defined as appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types. MRD negativity was defined by two thresholds, 10^-5 and 10^-6.
Anytime from date of first dose until the first documentation of confirmed PD, death or start of new anticancer therapy whichever occurred first (maximum up to 34.3 months)
Part 2: Number of Participants With ADA and NAb Against PF-06863135
Number of participants with ADA and NAb against PF-06863135 were reported in this outcome measure. A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participant had >= 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a >= 4-folder dilution increase in titer from baseline in >= 1 post-treatment sample (treatment-boosted).
From first dose of the study treatment (Day 1) up to end of study treatment (maximum up to 34.3 months)
Part 2: Concentration of Soluble Cytokines in Serum
The concentration of Interleukin-2, Interleukin-6, Interferon-gamma and tumor necrosis factor-alpha were measured in this outcome measure.
Cycle 0 (0, 2, 4 and 8 hours post dose on Day 1, 24 hours post dose on Day 2); Cycle 1 (0, 2, 4 and 8 hours post dose on Day 1, 24 hours post dose on Day 2, 72 hours post dose on Day 3)
La Jolla
California
92037
United States
UC San Diego Moores Cancer Center
La Jolla
California
92037
United States
UC San Diego Medical Center - Hillcrest
San Diego
California
92103
United States
UCSD Medical Center - Vista
Vista
California
92081
United States
Blood and Marrow Transplant Group of Georgia
Atlanta
Georgia
30342
United States
Northside Hospital
Atlanta
Georgia
30342
United States
UChicago Medicine - River East
Chicago
Illinois
60611
United States
The University of Chicago Medical Center, CCD - Investigational Drug Service Pharmacy
Chicago
Illinois
60637
United States
University of Chicago Medical Center
Chicago
Illinois
60637
United States
UChicago Medicine at Ingalls - Flossmoor
Flossmoor
Illinois
60422
United States
UChicago Medicine Ingalls Memorial
Harvey
Illinois
60426
United States
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox
Illinois
60451
United States
The University of Chicago Medicine Center for Advanced Care Orland Park
Orland Park
Illinois
60462
United States
UChicago Medicine at Ingalls - Tinley Park
Tinley Park
Illinois
60477
United States
University of Iowa Hospitals and Clinics
Iowa City
Iowa
52242
United States
Ochsner Clinic Foundation
New Orleans
Louisiana
70121
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge
New Jersey
07920
United States
Memorial Sloan Kettering Cancer Center at Monmouth
Middletown
New Jersey
07748
United States
Memorial Sloan Kettering Cancer Center at Bergen
Montvale
New Jersey
07645
United States
Memorial Sloan Kettering Cancer Center at Commack
Commack
New York
11725
United States
Memorial Sloan Kettering Cancer Center at Westchester
Harrison
New York
10604
United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care
New York
New York
10021
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
Memorial Sloan Kettering Cancer Center at Nassau
Uniondale
New York
11553
United States
Duke University Health System: Adult Bone Marrow Transplant Clinic
Durham
North Carolina
27705
United States
Duke Cancer Center
Durham
North Carolina
27710
United States
Duke University Hospital
Durham
North Carolina
27710
United States
Henry Joyce Cancer Center
Nashville
Tennessee
37232
United States
Baylor University Medical Center
Dallas
Texas
75246
United States
Investigational Drug Services, Baylor University Medical Center
Dallas
Texas
75246
United States
Unit 57, Special Services Building
Calgary
Alberta
T2N 2T9
Canada
Tom Baker Cancer Centre
Calgary
Alberta
T2N 4N2
Canada
Cross Cancer Institute
Edmonton
Alberta
T6G 1Z2
Canada
University Health Network - Princess Margaret Cancer Centre
Toronto
Ontario
M5G2M9
Canada
MUHC, GLEN site
Montreal
Quebec
H4A3J1
Canada
Derived
Lon HK, Hibma J, Jiang S, Sullivan S, Vandendries E, Skoura A, Wang D, Elmeliegy M. Population Exposure-Response Efficacy Analysis of Elranatamab (PF-06863135) in Patients with Multiple Myeloma. Target Oncol. 2025 Sep;20(5):803-819. doi: 10.1007/s11523-025-01168-y. Epub 2025 Aug 18.
Elmeliegy M, Viqueira A, Vandendries E, Hickman A, Conte U, Irby D, Hibma J, Lon HK, Piscitelli J, Soltantabar P, Skoura A, Jiang S, Wang D. Dose Optimization of Elranatamab to Mitigate the Risk of Cytokine Release Syndrome in Patients with Multiple Myeloma. Target Oncol. 2025 Mar;20(2):349-359. doi: 10.1007/s11523-025-01134-8. Epub 2025 Feb 25.
Bahlis NJ, Costello CL, Raje NS, Levy MY, Dholaria B, Solh M, Tomasson MH, Damore MA, Jiang S, Basu C, Skoura A, Chan EM, Trudel S, Jakubowiak A, Gasparetto C, Chu MP, Dalovisio A, Sebag M, Lesokhin AM. Elranatamab in relapsed or refractory multiple myeloma: the MagnetisMM-1 phase 1 trial. Nat Med. 2023 Oct;29(10):2570-2576. doi: 10.1038/s41591-023-02589-w. Epub 2023 Oct 2.
FG001
Part 1: PF-06863135 0.3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
FG002
Part 1: PF-06863135 1 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
FG003
Part 1: PF-06863135 3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
FG004
Part 1: PF-06863135 10 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
FG005
Part 1: PF-06863135 30 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
FG006
Part 1: PF-06863135 50 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
FG007
Part 1: PF-06863135 80 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
FG008
Part 1: PF-06863135 130 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
FG009
Part 1: PF-06863135 215 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
FG010
Part 1: PF-06863135 360 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
FG011
Part 1: PF-06863135 600 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
FG012
Part 1: PF-06863135 1000 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
FG013
Part 1.1: PF-06863135 Priming Cohort Q1W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
FG014
Part 1.1: PF-06863135 Priming Cohort Q2W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
FG015
Part 1C: PF-06863135 + Lenalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
FG016
Part 1D: PF-06863135 + Pomalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
FG017
Part 2A: PF-06863135 SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
FG0002 subjects
FG0013 subjects
FG0022 subjects
FG0033 subjects
FG0042 subjects
FG0055 subjects
FG0066 subjects
FG0076 subjects
FG0084 subjects
FG0094 subjects
FG0104 subjects
FG0116 subjects
FG0126 subjects
FG0137 subjects
FG01413 subjects
FG0154 subjects
FG0169 subjects
FG0170 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
NOT COMPLETED
FG0002 subjects
FG0013 subjects
FG0022 subjects
FG0033 subjects
FG0042 subjects
FG0055 subjects
FG0066 subjects
FG0076 subjects
FG0084 subjects
FG0094 subjects
FG0104 subjects
FG0116 subjects
FG0126 subjects
FG0137 subjects
FG01413 subjects
FG0154 subjects
FG0169 subjects
FG0170 subjects
Type
Comment
Reasons
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0111 subjects
FG0121 subjects
FG0130 subjects
FG0143 subjects
FG0151 subjects
FG0161 subjects
FG0170 subjects
Refused Further Treatment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Global Deterioration of Health Status
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Disease Relapse
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Progressive Disease
FG0002 subjects
FG0013 subjects
FG0022 subjects
FG0033 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part 2A: Dose Expansion
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG01715 subjectsParticipants in this period were enrolled in Part 2A of the study.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: PF-06863135 0.1 mcg/kg IV
Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
BG001
Part 1: PF-06863135 0.3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
BG002
Part 1: PF-06863135 1 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
BG003
Part 1: PF-06863135 3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
BG004
Part 1: PF-06863135 10 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
BG005
Part 1: PF-06863135 30 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
BG006
Part 1: PF-06863135 50 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
BG007
Part 1: PF-06863135 80 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
BG008
Part 1: PF-06863135 130 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
BG009
Part 1: PF-06863135 215 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
BG010
Part 1: PF-06863135 360 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
BG011
Part 1: PF-06863135 600 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
BG012
Part 1: PF-06863135 1000 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
BG013
Part 1.1: PF-06863135 Priming Cohort Q1W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
BG014
Part 1.1: PF-06863135 Priming Cohort Q2W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
BG015
Part 1C: PF-06863135 + Lenalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
BG016
Part 1D: PF-06863135 + Pomalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
BG017
Part 2A: PF-06863135 SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
BG018
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0002
BG0013
BG0022
BG0033
BG0042
BG0055
BG0066
BG0076
BG0084
BG0094
BG0104
BG0116
BG0126
BG0137
BG01413
BG0154
BG0169
BG01715
BG018101
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00058.0± 4.24
BG00167.3± 4.04
BG00253.0± 0.00
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03
Hematological: Grade 4 neutropenia lasting >5 days; Febrile neutropenia <1000/mm^3 with a single temperature of >38.3 degree Celsius (C) or a sustained temperature of >=38 degree C for more than one hour; grade >=3 neutropenia with infection; grade 4 thrombocytopenia; grade 3 thrombocytopenia with >= Grade 2 bleeding. Non-hematological: grade 4 adverse events (AEs); Grade 3 AE lasting >=5 days despite optimal supportive care, with exception of AE attributed to cytokine release syndrome (CRS) event; grade 3 CRS, except those CRS that had a) not been maximally treated or b) improved to <=grade 1 within 48 hours; grade 4 CRS; confirmed drug-induced liver injury (DILI) meeting Hy's law criteria; grade 4 laboratory abnormalities deemed clinically significant by the investigator reported Grade 4 AE; clinically important or persistent toxicities that were not included in above criteria were also be considered a DLT following review by the investigators and the sponsor.
DLT evaluable set included all participants that had experienced a DLT in the DLT observation period or received all of their planned doses of PF-06863135 in the initial DLT observation period if Q2W dosing was being evaluated or at least all but one of their planned doses of PF-0686135 if Q1W dosing was being evaluated, provided a dose was not missed due to toxicity attributed to study drug.
Posted
Count of Participants
Participants
Cycle 1 (21 Days)
ID
Title
Description
OG000
Part 1: PF-06863135 0.1 mcg/kg IV
Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG001
Part 1: PF-06863135 0.3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG002
Part 1: PF-06863135 1 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG003
Part 1: PF-06863135 3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG004
Part 1: PF-06863135 10 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Units
Counts
Participants
OG0002
OG0013
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part 2: Objective Response Rate (ORR) as Per International Myeloma Working Group (IMWG) Criteria
ORR per IMWG criteria: percentage of participants with best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). sCR: complete response plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates. 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/24 hr. PR: >=50% reduction of serum M-protein and reduction in 24 hrs urinary M-protein by >=90% or to <200 mg/24 hr. If serum and urine M-protein were unmeasurable, >=50% decrease in difference between involved and uninvolved FLC levels required in place of the M-protein criteria.
Modified intent to treat (mITT) analysis set included all participants who have received at least one dose of study treatment.
Posted
Number
95% Confidence Interval
Percentage of participants
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34.3 months)
ID
Title
Description
OG000
Part 2A: PF-06863135 SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Primary
Part 2: Duration of Response (DOR) as Per IMWG Criteria
DOR per IMWG criteria:time from first documentation of objective tumor (OT)response to first documentation of OTprogression or to death due to any cause, whichever occurred first.sCR: CR plus normal FLC ratio & absence of clonal cells in bone marrow biopsy by immunohistochemistry;CR:Negative immunofixation on serum & urine & disappearance of any soft tissue plasmacytomas&<5% plasma cells in bone marrow aspirates.VGPR: serum & urine M-protein(Mp) detectable by immunofixation but not on electrophoresis or >=90% reduction in serum Mp plus urine Mp level <100 mg/24 hr. PR: >=50% reduction of serum Mp & reduction in 24 hrs urinary Mp by >=90% or to <200 mg/24 hr.If serum & urine Mp were unmeasurable, >=50% decrease in difference between involved & uninvolved FLC levels required in place of Mp criteria. Progression: appearance of local, regional or distant disease of same type after CR or progression of pre-existing lesions. It did not include second primary malignancies of unrelated types.
mITT analysis set included all participants who have received at least one dose of study treatment. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Median
95% Confidence Interval
Months
From the first documentation of objective tumor response to first documentation of objective tumor progression or new anti-cancer therapies or death, whichever occurred first, (maximum up to 34.3 months)
ID
Title
Description
OG000
Part 2A: PF-06863135 SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Secondary
Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03
AE: any untoward medical occurrence in clinical study participant, temporally associated with use of study intervention, whether or not considered related to intervention. TEAE: any event increasing in severity from baseline or event started during PF-06863135 therapy or within 30 days of last dose of drug. SAE: any untoward medical occurrence at any dose that resulted in either: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission via Pfizer product of infectious agent, pathogenic or non-pathogenic; or considered as important event. Treatment-related AE: AEs attributed to drug in participants who received drug. Relatedness was judged by investigator. NCI CTCAE v4.03, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. AEs included SAEs and all non-SAEs.
Safety analysis set included all participants who receive at least 1 full or partial dose of study medication.
Posted
Count of Participants
Participants
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 43.3 months)
ID
Title
Description
OG000
Part 1: PF-06863135 0.1 mcg/kg IV
Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Secondary
Part 1: Number of Participants With Shifts From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters
Hematology parameters included: activated partial thromboplastin time prolonged, anemia, hemoglobin increased, international normalized ratio (INR) increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and, white blood cell decreased. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of hematology parameters are reported.
Safety analysis set included all participants who receive at least 1 full or partial dose of study medication.
Posted
Count of Participants
Participants
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 43.3 months)
ID
Title
Description
OG000
Part 1: PF-06863135 0.1 mcg/kg IV
Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG001
Part 1: PF-06863135 0.3 mcg/kg IV
Secondary
Part 1: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters
Clinical chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia and hypophosphatemia. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of clinical chemistry parameters are reported.
Safety analysis set included all participants who receive at least 1 full or partial dose of study medication.
Posted
Count of Participants
Participants
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 43.3 months)
ID
Title
Description
OG000
Part 1: PF-06863135 0.1 mcg/kg IV
Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG001
Secondary
Part 1: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Urinalysis
Proteinuria was estimated in urinalysis. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of urinalysis parameters are reported.
Safety analysis set included all participants who receive at least 1 full or partial dose of study medication.
Posted
Count of Participants
Participants
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 43.3 months)
ID
Title
Description
OG000
Part 1: PF-06863135 0.1 mcg/kg IV
Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG001
Part 1: PF-06863135 0.3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Secondary
Part 1: ORR as Per IMWG Criteria
ORR per IMWG criteria: percentage of participants with best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). sCR: complete response plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates. 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/24 hr. PR: >=50% reduction of serum M-protein and reduction in 24 hrs urinary M-protein by >=90% or to <200 mg/24 hr. If serum and urine M-protein were unmeasurable, >=50% decrease in difference between involved and uninvolved FLC levels required in place of the M-protein criteria.
mITT analysis set included all participants who have received at least one dose of study treatment.
Posted
Number
95% Confidence Interval
Percentage of participants
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 63.31 months)
ID
Title
Description
OG000
Part 1: PF-06863135 0.1 mcg/kg IV
Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Secondary
Part 1: Time to Response (TTR) as Per IMWG Criteria
TTR: Defined for participants with confirmed objective response as time from first dose to first documentation of objective tumor response. sCR: complete response + normal FLC ratio & absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: Negative immunofixation on serum& urine & disappearance of soft tissue plasmacytomas & <5% plasma cells in bone marrow aspirates. VGPR: serum& urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein level <100 mg/24 hr. PR: >=50% reduction of serum M-protein& reduction in 24hrs urinary M-protein by >=90% or <200 mg/24hr. If serum & urine M-protein unmeasurable, >=50% decrease in difference between involved & uninvolved FLC levels required in place of M-protein criteria. Progression: Appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types.
mITT analysis set included all participants who have received at least one dose of study treatment. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and for arms where it is "0" signifies there was no participant with confirmed objective response.
Posted
Median
Full Range
Days
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 63.31 months)
ID
Title
Description
OG000
Part 1: PF-06863135 0.1 mcg/kg IV
Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Secondary
Part 1: Complete Response Rate (CRR) as Per IMWG Criteria
CRR: percentage of participants with complete response (sCR or CR). sCR: complete response plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates.
mITT analysis set included all participants who have received at least one dose of study treatment.
Posted
Number
95% Confidence Interval
Percentage of participants
From the first dose of study treatment until the first documented sCR or CR or new anti-cancer therapies or death, whichever occurred first (maximum up to 63.31 months)
ID
Title
Description
OG000
Part 1: PF-06863135 0.1 mcg/kg IV
Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG001
Part 1: PF-06863135 0.3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Secondary
Part 1: DOR as Per IMWG Criteria
DOR per IMWG criteria:time from first documentation of objective tumor (OT)response to first documentation of OTprogression or to death due to any cause, whichever occurred first.sCR: CR plus normal FLC ratio & absence of clonal cells in bone marrow biopsy by immunohistochemistry;CR:Negative immunofixation on serum & urine & disappearance of any soft tissue plasmacytomas&<5% plasma cells in bone marrow aspirates.VGPR: serum & urine M-protein(Mp) detectable by immunofixation but not on electrophoresis or >=90% reduction in serum Mp plus urine Mp level <100 mg/24 hr. PR: >=50% reduction of serum Mp & reduction in 24 hrs urinary Mp by >=90% or to <200 mg/24 hr.If serum & urine Mp were unmeasurable, >=50% decrease in difference between involved & uninvolved FLC levels required in place of Mp criteria. Progression: appearance of local, regional or distant disease of same type after CR or progression of pre-existing lesions. It did not include second primary malignancies of unrelated types.
mITT analysis set included all participants who have received at least one dose of study treatment. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and for arms where it is "0" signifies there was no participant with confirmed objective response.
Posted
Median
95% Confidence Interval
Months
From the first documentation of objective tumor response to first documentation of objective tumor progression or new anti-cancer therapies or death, whichever occurred first, (maximum up to 63.31 months)
ID
Title
Description
OG000
Part 1: PF-06863135 0.1 mcg/kg IV
Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Secondary
Part 1: Duration of Complete Response (DoCR) as Per IMWG Criteria
DoCR was defined for participants with confirmed complete response (sCR or CR) as the time from the first documentation of complete response to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. sCR: complete response plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates. Progression was defined as appearance of local, regional or distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types.
mITT analysis set included all participants who have received at least one dose of study treatment. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and for arms where it is "0" signifies there was no participant with complete response.
Posted
Median
95% Confidence Interval
Months
From the first documentation of complete response to the first documentation of tumor progression or death, whichever occurred first (maximum up to 63.31 months)
ID
Title
Description
OG000
Part 1: PF-06863135 0.1 mcg/kg IV
Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Secondary
Part 1: Duration of Stable Disease (DOSD) as Per IMWG Criteria
DOSD per IMWG criteria: participants with confirmed stable disease (SD): time from first documentation (doc) of objective SD to first doc of objective tumor progression (P)/death by any cause, whichever occurred first. SD: not meeting criteria for CR,VGPR, PR, MR or PD. CR: Negative immunofixation on serum & urine &disappearance of any soft tissue plasmacytomas &<5% plasma cells in bone marrow aspirates. VGPR: serum & urine M-protein (Mp) detectable by immunofixation but not on electrophoresis or >=90% reduction in serum Mp plus urine Mp level <100 mg/24 hr. PR: >=50% reduction of serum Mp & reduction in 24 hours urinary Mp by >=90% or<200 mg/24 hr. If serum & urine Mp were unmeasurable, >=50% decrease in difference between involved & uninvolved FLC levels required in place of Mp criteria. Progression: appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types.
mITT analysis set included all participants who have received at least one dose of study treatment. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and for arm where it is "0" signifies there was no participant with stable disease.
Posted
Median
95% Confidence Interval
Months
Time from the first documentation of objective stable disease to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first (maximum up to 63.31 months)
ID
Title
Description
OG000
Part 1: PF-06863135 0.1 mcg/kg IV
Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Secondary
Part 1: Progression Free Survival (PFS) as Per IMWG Criteria
PFS as per IMWG criteria was the time from start date of study treatment to date of first documentation of progression, or death due to any cause. Progression was defined as the appearance of local, regional or distant disease of the same type after CR or progression of pre-existing lesions. It does not include second primary malignancies of unrelated types. CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates.
mITT analysis set included all participants who have received at least one dose of study treatment.
Posted
Median
95% Confidence Interval
Months
From start date of study treatment to date of first documentation of progression or death due to any cause, whichever occurred first (maximum up to 63.31 months)
ID
Title
Description
OG000
Part 1: PF-06863135 0.1 mcg/kg IV
Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG001
Part 1: PF-06863135 0.3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Secondary
Part 1: Overall Survival (OS)
OS was defined as the time from start date of study treatment to date of death due to any cause. OS for participants not known to had died were censored on the date of last known alive.
mITT analysis set included all participants who have received at least one dose of study treatment.
Posted
Median
95% Confidence Interval
Months
Time from start date of study treatment to date of death due to any cause or last-known-alive date, whichever occurred first (maximum up to 63.31 months)
ID
Title
Description
OG000
Part 1: PF-06863135 0.1 mcg/kg IV
Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG001
Part 1: PF-06863135 0.3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG002
Secondary
Part 1: Percentage of Participants With Negative Minimal Residual Disease (MRD) Using IMWG MRD Criteria
MRD negativity rate: percentage of participants with negative MRD (assessed by central laboratory) per IMWG criteria at any time from date of first dose until first documentation of confirmed progression, death or start of new anticancer therapy, whichever occurred first. Progression was defined as appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types. MRD negativity was defined by two thresholds, 10^-5 and 10^-6.
Safety Analysis set included all participants who received at least 1 full or partial dose of study medication.
Posted
Number
Percentage of participants
Anytime from date of first dose until the first documentation of confirmed PD, death or start of new anticancer therapy, whichever occurred first (maximum up to 63.31 months)
ID
Title
Description
OG000
Part 1: PF-06863135 0.1 mcg/kg IV
Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG001
Part 1: PF-06863135 0.3 mcg/kg IV
Secondary
Part 1: Maximum Observed Concentration (Cmax) of PF-06863135
Cmax of PF-06863135 was measured in this outcome measure. Total is free and bound drug in the body.
Pharmacokinetic (PK) parameter analysis set was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PF- 06863135 PK parameters of interest. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Micrograms per milliliter
0 hours (h) on Day 1 of Cycle (C) 0; 0, 2 and 4h on Day 1 of C1 and C2
ID
Title
Description
OG000
Part 1: PF-06863135 0.1 mcg/kg IV
Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG001
Part 1: PF-06863135 0.3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Secondary
Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau)
Area under the concentration curve from time 0 to end of dosing interval (AUCtau) was measured in this outcome measure. Total is free and bound drug in the body.
PK parameter analysis set was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PF- 06863135 PK parameters of interest. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified rows.
Posted
Geometric Mean
Geometric Coefficient of Variation
Microgram*day per milliliter
0 hours (h) on Day 1 of Cycle (C) 0; 0, 2 and 4h on Day 1 of C1 and C2
ID
Title
Description
OG000
Part 1: PF-06863135 0.1 mcg/kg IV
Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG001
Part 1: PF-06863135 0.3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Secondary
Part 1C and Part 1D: Plasma Concentration of Lenalidomide and Pomalidomide
Plasma concentration of lenalidomide and pomalidomide was measured in this outcome measure.
PK Concentration Analysis Set was defined as all participants randomized and treated who had at least 1 measurable PF-06863135 concentration.
Posted
Median
Full Range
nanogram/milliliter
Cycle 1 (0 hours post dose on Day 1, 8 and 15); Cycle 2 (0 hours on Day 15)
ID
Title
Description
OG000
Part 1C: PF-06863135 + Lenalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG001
Part 1D: PF-06863135 + Pomalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Secondary
Part 1: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-06863135
Number of participants with ADA and NAb against PF-06863135 were reported in this outcome measure. A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participant had >= 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a >= 4-folder dilution increase in titer from baseline in >= 1 post-treatment sample (treatment-boosted).
The immunogenicity analysis set was defined as participants who received at least 1 dose of study treatment and have at least 1 ADA sample collected. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
From first dose of the study treatment (Day 1) up to end of study treatment (maximum up to 63.31 months)
ID
Title
Description
OG000
Part 1: PF-06863135 0.1 mcg/kg IV
Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG001
Part 1: PF-06863135 0.3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Secondary
Part 1: Concentration of Soluble Cytokines in Serum
The concentration of Interleukin-2, Interleukin-6, Interferon-gamma and tumor necrosis factor-alpha were measured in this outcome measure. Cycle = C.
The Pharmacodynamic (PD)/Biomarker analysis set included all enrolled participants with at least 1 of the PD/Biomarkers evaluated at pre- and/or post-dose. Here, "Number Analyzed" signifies participants evaluable for specified rows.
Posted
Median
Full Range
Picogram per milliliter
Part 1: C1 (0, 2, 4 & 8 hours [h] post dose on Day [D] 1, 24h post dose on D2, 72h post dose on D3); Part 1.1, 1C & 1D: C0 (0, 2, 4 & 8h post dose on D1, 24h post dose on D2); C1 (0, 2, 4 & 8h post dose on D1, 24h post dose on D2, 72h post dose on D3)
ID
Title
Description
OG000
Part 1: PF-06863135 0.1 mcg/kg IV
Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG001
Part 1: PF-06863135 0.3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Secondary
Part 2: Number of Participants With AEs, Serious AEs, Treatment Related AEs, Grade 3 or 4 AEs and Grade 5 AEs as Graded by NCI CTCAE v4.03
AE: any untoward medical occurrence in clinical study participant, temporally associated with use of study intervention, whether or not considered related to intervention. TEAE: any event increasing in severity from baseline or event started during PF-06863135 therapy or within 30 days of last dose of drug. SAE: any untoward medical occurrence at any dose that resulted in either: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission via Pfizer product of infectious agent, pathogenic or non-pathogenic; or considered as important event. Treatment-related AE: AEs attributed to drug in participants who received drug. Relatedness was judged by investigator. NCI CTCAE v4.03, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. AEs included SAEs and all non-SAEs.
Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Posted
Count of Participants
Participants
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 32.3 months)
ID
Title
Description
OG000
Part 2A: PF-06863135 SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Secondary
Part 2: Number of Participants With Shifts From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Hematology Parameters
Hematology parameters included: activated partial thromboplastin time prolonged, anemia, hemoglobin increased, international normalized ratio (INR) increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and, white blood cell decreased. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of hematology parameters are reported.
Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Posted
Count of Participants
Participants
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 32.3 months)
ID
Title
Description
OG000
Part 2A: PF-06863135 SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Secondary
Part 2: Number of Participants With Shifts From Grade <= 2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Chemistry Parameters
Clinical chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia and hypophosphatemia. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of clinical chemistry parameters are reported.
Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Posted
Count of Participants
Participants
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 32.3 months)
ID
Title
Description
OG000
Part 2A: PF-06863135 SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Secondary
Part 2: Number of Participants With Shifts From Grade <=2 to Grade 3 or 4 Post-Baseline in Urinalysis
Proteinuria was estimated in urinalysis. According to NCI CTCAE version 4.03: Grade 1= mild, Gade 2= moderate, Grade 3= severe AE, Grade 4= life-threatening, urgent intervention indicated, Grade 5= death related to AE. In this outcome measure number of participants with shifts from grade 2 at baseline to grade 3 or 4 post-baseline in any of urinalysis parameters are reported.
Safety analysis set included all participants who received at least 1 full or partial dose of study medication.
Posted
Count of Participants
Participants
From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (maximum up to of 32.3 months)
ID
Title
Description
OG000
Part 2A: PF-06863135 SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Units
Counts
Participants
Secondary
Part 2: CRR as Per IMWG Criteria
CRR: percentage of participants with complete response (sCR or CR). sCR: complete response plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates.
mITT analysis set included all participants who have received at least one dose of study treatment.
Posted
Number
95% Confidence Interval
Percentage of participants
From the first dose of study treatment until the first documented sCR or CR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34.3 months)
ID
Title
Description
OG000
Part 2A: PF-06863135 SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Units
Counts
Participants
Secondary
Part 2: DoCR as Per IMWG Criteria
DoCR was defined for participants with confirmed complete response (sCR or CR) as the time from the first documentation of complete response to the first documentation of objective tumor progression or to death due to any cause, whichever occured first. sCR: complete response plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates. Progression was defined as appearance of local, regional or distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types.
mITT analysis set included all participants who have received at least one dose of study treatment. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Months
From the first documentation of complete response to the first documentation of tumor progression or death, whichever occurred first (maximum up to 34.3 months)
ID
Title
Description
OG000
Part 2A: PF-06863135 SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Secondary
Part 2: TTR as Per IMWG Criteria
TTR: Defined for participants with confirmed objective response as time from first dose to first documentation of objective tumor response. sCR: complete response + normal FLC ratio & absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR: Negative immunofixation on serum& urine & disappearance of soft tissue plasmacytomas & <5% plasma cells in bone marrow aspirates. VGPR: serum& urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein level <100 mg/24 hr. PR: >=50% reduction of serum M-protein& reduction in 24hrs urinary M-protein by >=90% or <200 mg/24hr. If serum & urine M-protein unmeasurable, >=50% decrease in difference between involved & uninvolved FLC levels required in place of M-protein criteria. Progression: Appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types.
mITT analysis set included all participants who have received at least one dose of study treatment. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Median
Full Range
Days
From the first dose of study treatment until the first documented sCR or CR or PR or VGPR or new anti-cancer therapies or death, whichever occurred first (maximum up to 34.3 months)
ID
Title
Description
OG000
Part 2A: PF-06863135 SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Secondary
Part 2: DOSD as Per IMWG Criteria
DOSD per IMWG criteria: participants with confirmed stable disease (SD): time from first documentation (doc) of objective SD to first doc of objective tumor progression (P)/death by any cause, whichever occurred first. SD: not meeting criteria for CR,VGPR, PR, MR or PD. CR: Negative immunofixation on serum & urine &disappearance of any soft tissue plasmacytomas &<5% plasma cells in bone marrow aspirates. VGPR: serum & urine M-protein (Mp) detectable by immunofixation but not on electrophoresis or >=90% reduction in serum Mp plus urine Mp level <100 mg/24 hr. PR: >=50% reduction of serum Mp & reduction in 24 hours urinary Mp by >=90% or<200 mg/24 hr. If serum & urine Mp were unmeasurable, >=50% decrease in difference between involved & uninvolved FLC levels required in place of Mp criteria. Progression: appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types.
mITT analysis set included all participants who have received at least one dose of study treatment. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Median
95% Confidence Interval
Months
Time from the first documentation of objective stable disease to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first (maximum up to 34.3 months)
ID
Title
Description
OG000
Part 2A: PF-06863135 SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Secondary
Part 2: PFS as Per IMWG Criteria
PFS as per IMWG criteria was the time from start date of study treatment to date of first documentation of progression, or death due to any cause. Progression was defined as the appearance of local, regional or distant disease of the same type after CR or progression of pre-existing lesions. It does not include second primary malignancies of unrelated types. CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates.
mITT analysis set included all participants who have received at least one dose of study treatment.
Posted
Median
95% Confidence Interval
Months
From start date of study treatment to date of first documentation of progression or death due to any cause, whichever occurred first (maximum up to 34.3 months)
ID
Title
Description
OG000
Part 2A: PF-06863135 SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Units
Counts
Participants
Secondary
Part 2: OS
OS was defined as the time from start date of study treatment to date of death due to any cause. OS for participants not known to had died were censored on the date of last known alive.
mITT analysis set included all participants who have received at least one dose of study treatment.
Posted
Median
95% Confidence Interval
Months
Time from start date of study treatment to date of death due to any cause or last-known-alive date, whichever occurred first (maximum up to 34.3 months)
ID
Title
Description
OG000
Part 2A: PF-06863135 SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Units
Counts
Participants
OG000
Secondary
Part 2: Percentage of Participants With Negative MRD After Treatment With PF-06863135 Using IMWG MRD Criteria
MRD negativity rate: percentage of participants with negative MRD (assessed by central laboratory) per IMWG criteria at any time from date of first dose until first documentation of confirmed progression, death or start of new anticancer therapy, whichever occurred first. Progression was defined as appearance of local, regional, distant disease of same type after CR or progression of pre-existing lesions. It didn't include second primary malignancies of unrelated types. MRD negativity was defined by two thresholds, 10^-5 and 10^-6.
Safety Analysis set included all participants who received at least 1 full or partial dose of study medication.
Posted
Number
Percentage of Participants
Anytime from date of first dose until the first documentation of confirmed PD, death or start of new anticancer therapy whichever occurred first (maximum up to 34.3 months)
ID
Title
Description
OG000
Part 2A: PF-06863135 SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Units
Secondary
Part 2: Number of Participants With ADA and NAb Against PF-06863135
Number of participants with ADA and NAb against PF-06863135 were reported in this outcome measure. A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participant had >= 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a >= 4-folder dilution increase in titer from baseline in >= 1 post-treatment sample (treatment-boosted).
The immunogenicity analysis set was defined as participants who received at least 1 dose of study treatment and have at least 1 ADA sample collected.
Posted
Count of Participants
Participants
From first dose of the study treatment (Day 1) up to end of study treatment (maximum up to 34.3 months)
ID
Title
Description
OG000
Part 2A: PF-06863135 SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Units
Counts
Participants
Secondary
Part 2: Concentration of Soluble Cytokines in Serum
The concentration of Interleukin-2, Interleukin-6, Interferon-gamma and tumor necrosis factor-alpha were measured in this outcome measure.
The PD/Biomarker analysis set included all enrolled participants with at least 1 of the PD/Biomarkers evaluated at pre- and/or post-dose. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies participants evaluable for specified rows.
Posted
Median
Full Range
Picogram per milliliter
Cycle 0 (0, 2, 4 and 8 hours post dose on Day 1, 24 hours post dose on Day 2); Cycle 1 (0, 2, 4 and 8 hours post dose on Day 1, 24 hours post dose on Day 2, 72 hours post dose on Day 3)
ID
Title
Description
OG000
Part 2A: PF-06863135 SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Units
Counts
Participants
Time Frame
Adverse events for Part 1: up to 43.3 months and for Part 2: up to 32.3 months; all-cause mortality for Part 1: 63.31 months and for Part 2: 34.3 months
Description
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set included all participants who received at least 1 full or partial dose of study 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
Part 1: PF-06863135 0.1 mcg/kg IV
Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
2
2
0
2
2
2
EG001
Part 1: PF-06863135 0.3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
2
3
1
3
3
3
EG002
Part 1: PF-06863135 1 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
2
2
0
2
2
2
EG003
Part 1: PF-06863135 3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
3
3
3
3
3
3
EG004
Part 1: PF-06863135 10 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
2
2
0
2
2
2
EG005
Part 1: PF-06863135 30 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
4
5
2
5
5
5
EG006
Part 1: PF-06863135 50 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
4
6
5
6
6
6
EG007
Part 1: PF-06863135 80 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
5
6
4
6
6
6
EG008
Part 1: PF-06863135 130 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
1
4
1
4
4
4
EG009
Part 1: PF-06863135 215 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
3
4
3
4
4
4
EG010
Part 1: PF-06863135 360 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
3
4
3
4
4
4
EG011
Part 1: PF-06863135 600 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
3
6
4
6
6
6
EG012
Part 1: PF-06863135 1000 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
2
6
5
6
6
6
EG013
Part 1.1: PF-06863135 Priming Cohort Q1W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
3
7
6
7
7
7
EG014
Part 1.1: PF-06863135 Priming Cohort Q2W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
4
13
9
13
13
13
EG015
Part 1C: PF-06863135 + Lenalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
2
4
2
4
4
4
EG016
Part 1D: PF-06863135 + Pomalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
4
9
8
9
9
9
EG017
Part 2A: PF-06863135 SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
10
15
12
15
13
15
EG018
Part 1: PF-06863135 Total IV
Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
19
23
11
23
23
23
EG019
Part 1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
17
30
20
30
30
30
EG020
Part 1.1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
7
20
15
20
20
20
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG0031 affected3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected4 at risk
EG0091 affected4 at risk
EG0100 affected4 at risk
EG0110 affected6 at risk
EG0120 affected6 at risk
EG0130 affected7 at risk
EG0140 affected13 at risk
EG0150 affected4 at risk
EG0160 affected9 at risk
EG0170 affected15 at risk
EG0181 affected23 at risk
EG0191 affected30 at risk
EG0200 affected20 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Diplopia
Eye disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Extraocular muscle disorder
Eye disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Asthenia
General disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Disease progression
General disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Fatigue
General disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Malaise
General disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Pyrexia
General disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Sudden death
General disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Adenovirus infection
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Appendicitis
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Bacterial sepsis
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Bronchopulmonary aspergillosis
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
COVID-19
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Cytomegalovirus chorioretinitis
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Encephalitis
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Extradural abscess
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Herpes simplex oesophagitis
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Salmonellosis
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Sepsis
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Septic shock
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Tracheobronchitis
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0011 affected3 at risk
EG0020 affected2 at risk
EG003
Viral sinusitis
Infections and infestations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Electrocardiogram T wave abnormal
Investigations
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Haematoma muscle
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v26.1
Non-systematic Assessment
EG0000 affected2 at risk
EG0010 affected3 at risk
EG0020 affected2 at risk
EG003
Plasma cell myeloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG006
Part 1: PF-06863135 50 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG007
Part 1: PF-06863135 80 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG008
Part 1: PF-06863135 130 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG009
Part 1: PF-06863135 215 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG010
Part 1: PF-06863135 360 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG011
Part 1: PF-06863135 600 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG012
Part 1: PF-06863135 1000 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG013
Part 1.1: PF-06863135 Priming Cohort Q1W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG014
Part 1.1: PF-06863135 Priming Cohort Q2W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG015
Part 1C: PF-06863135 + Lenalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG016
Part 1D: PF-06863135 + Pomalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG017
Part 1: PF-06863135 Total IV
Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG018
Part 1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG019
Part 1.1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
3
OG0042
OG0055
OG0066
OG0076
OG0084
OG0094
OG0104
OG0116
OG0126
OG0135
OG0149
OG0152
OG0166
OG01723
OG01830
OG01914
0
OG0040
OG0051
OG0061
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0141
OG0151
OG0163
OG0172
OG0180
OG0191
Units
Counts
Participants
OG00015
Title
Denominators
Categories
Title
Measurements
OG00060.0(35.7 to 80.2)
Units
Counts
Participants
OG0009
Title
Denominators
Categories
Title
Measurements
OG00011.6(2.5 to NA)The upper limit of 95% confidence interval (CI) was not estimable due to insufficient number of participants with events.
OG001
Part 1: PF-06863135 0.3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG002
Part 1: PF-06863135 1 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG003
Part 1: PF-06863135 3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG004
Part 1: PF-06863135 10 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG005
Part 1: PF-06863135 30 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG006
Part 1: PF-06863135 50 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG007
Part 1: PF-06863135 80 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG008
Part 1: PF-06863135 130 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG009
Part 1: PF-06863135 215 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG010
Part 1: PF-06863135 360 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG011
Part 1: PF-06863135 600 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG012
Part 1: PF-06863135 1000 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG013
Part 1.1: PF-06863135 Priming Cohort Q1W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG014
Part 1.1: PF-06863135 Priming Cohort Q2W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG015
Part 1C: PF-06863135 + Lenalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG016
Part 1D: PF-06863135 + Pomalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG017
Part 1: PF-06863135 Total IV
Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG018
Part 1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG019
Part 1.1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Units
Counts
Participants
OG0002
OG0013
OG0022
OG0033
OG0042
OG0055
OG0066
OG0076
OG0084
OG0094
OG0104
OG0116
OG0126
OG0137
OG01413
OG0154
OG0169
OG01723
OG01830
OG01920
Title
Denominators
Categories
Participants with AEs
Title
Measurements
OG0002
OG0013
OG0022
OG0033
OG0042
OG0055
OG0066
OG0076
OG0084
OG0094
OG0104
OG0116
OG0126
OG0137
OG01413
OG0154
OG0169
OG01723
OG01830
OG01920
Participants with serious TEAEs
Title
Measurements
OG0000
OG0011
OG0020
OG003
Participants with treatment related AEs
Title
Measurements
OG0002
OG0011
OG0021
OG003
Participants with grade 3 or 4 AEs
Title
Measurements
OG0001
OG0012
OG0021
OG003
Participants with grade 5 AEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG002
Part 1: PF-06863135 1 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG003
Part 1: PF-06863135 3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG004
Part 1: PF-06863135 10 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG005
Part 1: PF-06863135 30 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG006
Part 1: PF-06863135 50 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG007
Part 1: PF-06863135 80 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG008
Part 1: PF-06863135 130 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG009
Part 1: PF-06863135 215 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG010
Part 1: PF-06863135 360 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG011
Part 1: PF-06863135 600 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG012
Part 1: PF-06863135 1000 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG013
Part 1.1: PF-06863135 Priming Cohort Q1W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG014
Part 1.1: PF-06863135 Priming Cohort Q2W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG015
Part 1C: PF-06863135 + Lenalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG016
Part 1D: PF-06863135 + Pomalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG017
Part 1: PF-06863135 Total IV
Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG018
Part 1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG019
Part 1.1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Units
Counts
Participants
OG0002
OG0013
OG0022
OG0033
OG0042
OG0055
OG0066
OG0076
OG0084
OG0094
OG0104
OG0116
OG0126
OG0137
OG01413
OG0154
OG0169
OG01723
OG01830
OG01920
Title
Denominators
Categories
Title
Measurements
OG0001
OG0012
OG0022
OG0032
OG0042
OG0055
OG0065
OG0076
OG0083
OG0094
OG0104
OG0116
OG0126
OG0136
OG01413
OG0154
OG0169
OG01719
OG01829
OG01919
Part 1: PF-06863135 0.3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG002
Part 1: PF-06863135 1 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG003
Part 1: PF-06863135 3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG004
Part 1: PF-06863135 10 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG005
Part 1: PF-06863135 30 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG006
Part 1: PF-06863135 50 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG007
Part 1: PF-06863135 80 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG008
Part 1: PF-06863135 130 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG009
Part 1: PF-06863135 215 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG010
Part 1: PF-06863135 360 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG011
Part 1: PF-06863135 600 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG012
Part 1: PF-06863135 1000 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG013
Part 1.1: PF-06863135 Priming Cohort Q1W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG014
Part 1.1: PF-06863135 Priming Cohort Q2W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG015
Part 1C: PF-06863135 + Lenalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG016
Part 1D: PF-06863135 + Pomalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG017
Part 1: PF-06863135 Total IV
Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG018
Part 1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG019
Part 1.1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Units
Counts
Participants
OG0002
OG0013
OG0022
OG0033
OG0042
OG0055
OG0066
OG0076
OG0084
OG0094
OG0104
OG0116
OG0126
OG0137
OG01413
OG0154
OG0169
OG01723
OG01830
OG01920
Title
Denominators
Categories
Title
Measurements
OG0000
OG0012
OG0020
OG0031
OG0040
OG0052
OG0061
OG0072
OG0080
OG0092
OG0102
OG0113
OG0122
OG0133
OG0148
OG0154
OG0163
OG0176
OG01811
OG01911
OG002
Part 1: PF-06863135 1 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG003
Part 1: PF-06863135 3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG004
Part 1: PF-06863135 10 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG005
Part 1: PF-06863135 30 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG006
Part 1: PF-06863135 50 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG007
Part 1: PF-06863135 80 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG008
Part 1: PF-06863135 130 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG009
Part 1: PF-06863135 215 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG010
Part 1: PF-06863135 360 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG011
Part 1: PF-06863135 600 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG012
Part 1: PF-06863135 1000 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG013
Part 1.1: PF-06863135 Priming Cohort Q1W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG014
Part 1.1: PF-06863135 Priming Cohort Q2W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG015
Part 1C: PF-06863135 + Lenalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG016
Part 1D: PF-06863135 + Pomalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG017
Part 1: PF-06863135 Total IV
Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG018
Part 1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG019
Part 1.1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Units
Counts
Participants
OG0002
OG0013
OG0022
OG0033
OG0042
OG0055
OG0066
OG0076
OG0084
OG0094
OG0104
OG0116
OG0126
OG0137
OG01413
OG0154
OG0169
OG01723
OG01830
OG01920
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG0160
OG0170
OG0180
OG0190
OG001
Part 1: PF-06863135 0.3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG002
Part 1: PF-06863135 1 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG003
Part 1: PF-06863135 3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG004
Part 1: PF-06863135 10 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG005
Part 1: PF-06863135 30 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG006
Part 1: PF-06863135 50 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG007
Part 1: PF-06863135 80 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG008
Part 1: PF-06863135 130 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG009
Part 1: PF-06863135 215 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG010
Part 1: PF-06863135 360 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG011
Part 1: PF-06863135 600 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG012
Part 1: PF-06863135 1000 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG013
Part 1.1: PF-06863135 Priming Cohort Q1W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG014
Part 1.1: PF-06863135 Priming Cohort Q2W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG015
Part 1C: PF-06863135 + Lenalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG016
Part 1D: PF-06863135 + Pomalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG017
Part 1: PF-06863135 Total IV
Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG018
Part 1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG019
Part 1.1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Units
Counts
Participants
OG0002
OG0013
OG0022
OG0033
OG0042
OG0055
OG0066
OG0076
OG0084
OG0094
OG0104
OG0116
OG0126
OG0137
OG01413
OG0154
OG0169
OG01723
OG01830
OG01920
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 65.8)
OG0010(0.0 to 56.1)
OG0020(0.0 to 65.8)
OG0030(0.0 to 56.1)
OG0040(0.0 to 65.8)
OG0050(0.0 to 43.4)
OG0060(0.0 to 39.0)
OG0070(0.0 to 39.0)
OG0080(0.0 to 49.0)
OG00950.0(15.0 to 85.0)
OG01075.0(30.1 to 95.4)
OG01166.7(30.0 to 90.3)
OG01283.3(43.6 to 97.0)
OG01357.1(25.0 to 84.2)
OG01461.5(25.5 to 82.3)
OG01575.0(30.1 to 95.4)
OG01677.8(45.3 to 93.7)
OG0170(0.0 to 14.3)
OG01846.7(30.2 to 63.9)
OG01960.0(38.7 to 78.1)
OG001
Part 1: PF-06863135 0.3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG002
Part 1: PF-06863135 1 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG003
Part 1: PF-06863135 3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG004
Part 1: PF-06863135 10 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG005
Part 1: PF-06863135 30 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG006
Part 1: PF-06863135 50 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG007
Part 1: PF-06863135 80 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG008
Part 1: PF-06863135 130 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG009
Part 1: PF-06863135 215 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG010
Part 1: PF-06863135 360 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG011
Part 1: PF-06863135 600 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG012
Part 1: PF-06863135 1000 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG013
Part 1.1: PF-06863135 Priming Cohort Q1W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG014
Part 1.1: PF-06863135 Priming Cohort Q2W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG015
Part 1C: PF-06863135 + Lenalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG016
Part 1D: PF-06863135 + Pomalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG017
Part 1: PF-06863135 Total IV
Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG018
Part 1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG019
Part 1.1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0092
OG0103
OG0114
OG0125
OG0134
OG0148
OG0153
OG0167
OG0170
OG01814
OG01912
Title
Denominators
Categories
Title
Measurements
OG00922.0(22 to 22)
OG01022.0(22 to 24)
OG01122.0(21 to 23)
OG01242.0(22 to 92)
OG01339.0(8 to 65)
OG01436.0(7 to 73)
OG01552.0(8 to 281)
OG01650.0(7 to 105)
OG01822.0(21 to 92)
OG01936.0(7 to 73)
OG002
Part 1: PF-06863135 1 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG003
Part 1: PF-06863135 3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG004
Part 1: PF-06863135 10 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG005
Part 1: PF-06863135 30 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG006
Part 1: PF-06863135 50 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG007
Part 1: PF-06863135 80 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG008
Part 1: PF-06863135 130 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG009
Part 1: PF-06863135 215 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG010
Part 1: PF-06863135 360 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG011
Part 1: PF-06863135 600 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG012
Part 1: PF-06863135 1000 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG013
Part 1.1: PF-06863135 Priming Cohort Q1W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG014
Part 1.1: PF-06863135 Priming Cohort Q2W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG015
Part 1C: PF-06863135 + Lenalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG016
Part 1D: PF-06863135 + Pomalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG017
Part 1: PF-06863135 Total IV
Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG018
Part 1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG019
Part 1.1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Units
Counts
Participants
OG0002
OG0013
OG0022
OG0033
OG0042
OG0055
OG0066
OG0076
OG0084
OG0094
OG0104
OG0116
OG0126
OG0137
OG01413
OG0154
OG0169
OG01723
OG01830
OG01920
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 65.8)
OG0010(0.0 to 56.1)
OG0020(0.0 to 65.8)
OG0030(0.0 to 56.1)
OG0040(0.0 to 65.8)
OG0050(0.0 to 43.4)
OG0060(0.0 to 39.0)
OG0070(0.0 to 39.0)
OG0080(0.0 to 49.0)
OG00950.0(15.0 to 85.0)
OG01025.0(4.6 to 69.9)
OG01150.0(18.8 to 81.2)
OG01250.0(18.8 to 81.2)
OG01314.3(2.6 to 51.3)
OG01446.2(23.2 to 70.9)
OG01550.0(15.0 to 85.0)
OG01633.3(12.1 to 64.6)
OG0170(0.0 to 14.3)
OG01830.0(16.7 to 47.9)
OG01935.0(18.1 to 56.7)
OG001
Part 1: PF-06863135 0.3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG002
Part 1: PF-06863135 1 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG003
Part 1: PF-06863135 3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG004
Part 1: PF-06863135 10 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG005
Part 1: PF-06863135 30 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG006
Part 1: PF-06863135 50 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG007
Part 1: PF-06863135 80 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG008
Part 1: PF-06863135 130 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG009
Part 1: PF-06863135 215 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG010
Part 1: PF-06863135 360 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG011
Part 1: PF-06863135 600 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG012
Part 1: PF-06863135 1000 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG013
Part 1.1: PF-06863135 Priming Cohort Q1W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG014
Part 1.1: PF-06863135 Priming Cohort Q2W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG015
Part 1C: PF-06863135 + Lenalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG016
Part 1D: PF-06863135 + Pomalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG017
Part 1: PF-06863135 Total IV
Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG018
Part 1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG019
Part 1.1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0092
OG0103
OG0114
OG0125
OG0134
OG0148
OG0153
OG0167
OG0170
OG01814
OG01912
Title
Denominators
Categories
Title
Measurements
OG00925.3(18.4 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG01013.6(5.4 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG011NA(32.2 to NA)The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG012NA(6.3 to NA)The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG0136.7(3.7 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG01417.1(10.6 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG01514.9(11.8 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG0168.3(2.9 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG01832.2(7.0 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG01913.3(6.3 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG001
Part 1: PF-06863135 0.3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG002
Part 1: PF-06863135 1 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG003
Part 1: PF-06863135 3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG004
Part 1: PF-06863135 10 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG005
Part 1: PF-06863135 30 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG006
Part 1: PF-06863135 50 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG007
Part 1: PF-06863135 80 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG008
Part 1: PF-06863135 130 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG009
Part 1: PF-06863135 215 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG010
Part 1: PF-06863135 360 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG011
Part 1: PF-06863135 600 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG012
Part 1: PF-06863135 1000 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG013
Part 1.1: PF-06863135 Priming Cohort Q1W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG014
Part 1.1: PF-06863135 Priming Cohort Q2W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG015
Part 1C: PF-06863135 + Lenalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG016
Part 1D: PF-06863135 + Pomalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG017
Part 1: PF-06863135 Total IV
Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG018
Part 1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG019
Part 1.1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0092
OG0101
OG0113
OG0123
OG0131
OG0146
OG0152
OG0163
OG0170
OG0189
OG0199
Title
Denominators
Categories
Title
Measurements
OG00925.3(18.4 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG010NA(NA to NA)Median and CI could not be reported as participant did not have event.
OG011NA(NA to NA)Only one participant had event, hence median and CI not reported. Individual participant data was 31.5 months.
OG012NA(7.0 to NA)The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG013NA(NA to NA)Only one participant was evaluable and had event, hence median and CI not reported. Individual participant data was 1.9 months.
OG014NA(6.5 to NA)The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events
OG015NA(10.3 to NA)The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG016NA(3.7 to NA)The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG01831.5(7.0 to NA)The upper limit of 95% CI was not estimable due to low number of participants with events.
OG01911.5(1.9 to NA)The upper limit of 95% CI was not estimable due to low number of participants with events.
OG001
Part 1: PF-06863135 0.3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG002
Part 1: PF-06863135 1 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG003
Part 1: PF-06863135 3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG004
Part 1: PF-06863135 10 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG005
Part 1: PF-06863135 30 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG006
Part 1: PF-06863135 50 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG007
Part 1: PF-06863135 80 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG008
Part 1: PF-06863135 130 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG009
Part 1: PF-06863135 215 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG010
Part 1: PF-06863135 360 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG011
Part 1: PF-06863135 600 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG012
Part 1: PF-06863135 1000 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG013
Part 1.1: PF-06863135 Priming Cohort Q1W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG014
Part 1.1: PF-06863135 Priming Cohort Q2W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG015
Part 1C: PF-06863135 + Lenalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG016
Part 1D: PF-06863135 + Pomalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG017
Part 1: PF-06863135 Total IV
Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG018
Part 1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG019
Part 1.1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Units
Counts
Participants
OG0000
OG0012
OG0021
OG0032
OG0041
OG0053
OG0064
OG0074
OG0082
OG0094
OG0103
OG0115
OG0125
OG0136
OG0149
OG0154
OG0169
OG01713
OG01823
OG01915
Title
Denominators
Categories
Title
Measurements
OG0011.3(0.5 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG002NA(NA to NA)Only one participant was evaluable and had event, hence median and CI not reported. Individual participant data was 0.7 months.
OG0030.8(0.6 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG004NA(NA to NA)Only one participant was evaluable and had event, hence median and CI not reported. Individual participant data was 1.8 months.
OG0053.4(1.0 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG0063.0(2.2 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG0070.4(0.3 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG0080.6(0.5 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG00918.4(4.2 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG01013.6(5.4 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG01132.2(2.1 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG012NA(7.0 to NA)The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG0137.4(3.7 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG01417.6(11.5 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG01517.9(1.5 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG0165.6(0.7 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG0171.8(0.6 to 3.4)
OG0187.3(1.4 to 32.3)
OG01912.0(7.4 to 20.2)
OG002
Part 1: PF-06863135 1 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG003
Part 1: PF-06863135 3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG004
Part 1: PF-06863135 10 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG005
Part 1: PF-06863135 30 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG006
Part 1: PF-06863135 50 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG007
Part 1: PF-06863135 80 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG008
Part 1: PF-06863135 130 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG009
Part 1: PF-06863135 215 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG010
Part 1: PF-06863135 360 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG011
Part 1: PF-06863135 600 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG012
Part 1: PF-06863135 1000 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG013
Part 1.1: PF-06863135 Priming Cohort Q1W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG014
Part 1.1: PF-06863135 Priming Cohort Q2W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG015
Part 1C: PF-06863135 + Lenalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG016
Part 1D: PF-06863135 + Pomalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG017
Part 1: PF-06863135 Total IV
Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG018
Part 1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG019
Part 1.1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Units
Counts
Participants
OG0002
OG0013
OG0022
OG0033
OG0042
OG0055
OG0066
OG0076
OG0084
OG0094
OG0104
OG0116
OG0126
OG0137
OG01413
OG0154
OG0169
OG01723
OG01830
OG01920
Title
Denominators
Categories
Title
Measurements
OG0000.4(0.3 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG0010.7(0.3 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG0021.1(0.7 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG0031.7(0.6 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG0041.6(0.6 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG0051.6(0.6 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG0062.9(0.8 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG0071.0(0.7 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG0081.0(0.7 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG00919.1(4.8 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG01010.2(0.7 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG01132.9(0.7 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG0128.0(0.7 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG0137.6(3.9 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG01412.7(0.5 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG01518.1(1.7 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG0166.7(0.9 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG0171.4(0.6 to 2.6)
OG0184.8(1.1 to 14.4)
OG01912.2(3.9 to 19.2)
Part 1: PF-06863135 1 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG003
Part 1: PF-06863135 3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG004
Part 1: PF-06863135 10 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG005
Part 1: PF-06863135 30 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG006
Part 1: PF-06863135 50 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG007
Part 1: PF-06863135 80 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG008
Part 1: PF-06863135 130 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG009
Part 1: PF-06863135 215 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG010
Part 1: PF-06863135 360 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG011
Part 1: PF-06863135 600 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG012
Part 1: PF-06863135 1000 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG013
Part 1.1: PF-06863135 Priming Cohort Q1W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG014
Part 1.1: PF-06863135 Priming Cohort Q2W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG015
Part 1C: PF-06863135 + Lenalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG016
Part 1D: PF-06863135 + Pomalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG017
Part 1: PF-06863135 Total IV
Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG018
Part 1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG019
Part 1.1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Units
Counts
Participants
OG0002
OG0013
OG0022
OG0033
OG0042
OG0055
OG0066
OG0076
OG0084
OG0094
OG0104
OG0116
OG0126
OG0137
OG01413
OG0154
OG0169
OG01723
OG01830
OG01920
Title
Denominators
Categories
Title
Measurements
OG0008.2(4.4 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG0018.4(1.9 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG00211.2(4.4 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG0038.1(1.7 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG00416.2(9.4 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG00514.8(2.4 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG00618.0(5.0 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG0071.7(0.8 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG008NA(3.8 to NA)The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG00919.1(8.8 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG01014.0(3.0 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG01132.9(12.0 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG012NA(2.2 to NA)The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG0138.3(3.9 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG014NA(1.1 to NA)The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG01531.3(28.3 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG016NA(5.7 to NA)The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
OG01712.0(7.9 to 17.1)
OG01817.3(6.2 to 44.8)
OG019NA(5.4 to NA)The median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG002
Part 1: PF-06863135 1 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG003
Part 1: PF-06863135 3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG004
Part 1: PF-06863135 10 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG005
Part 1: PF-06863135 30 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG006
Part 1: PF-06863135 50 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG007
Part 1: PF-06863135 80 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG008
Part 1: PF-06863135 130 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG009
Part 1: PF-06863135 215 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG010
Part 1: PF-06863135 360 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG011
Part 1: PF-06863135 600 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG012
Part 1: PF-06863135 1000 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG013
Part 1.1: PF-06863135 Priming Cohort Q1W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG014
Part 1.1: PF-06863135 Priming Cohort Q2W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG015
Part 1C: PF-06863135 + Lenalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG016
Part 1D: PF-06863135 + Pomalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG017
Part 1: PF-06863135 Total IV
Participants with relapsed/refractory advanced MM received PF-06863135 as an IV infusion (any dose) for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG018
Part 1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 as a SC injection (any dose) on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG019
Part 1.1: PF-06863135 Total SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection Q1W on Day 1, 8 ,15 and 22 of each 28-day cycle or Q2W on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Units
Counts
Participants
OG0002
OG0013
OG0022
OG0033
OG0042
OG0055
OG0066
OG0076
OG0084
OG0094
OG0104
OG0116
OG0126
OG0137
OG01413
OG0154
OG0169
OG01723
OG01830
OG01920
Title
Denominators
Categories
10^-5 threshold MRD
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG00950.00
OG0100
OG01116.67
OG01216.67
OG01328.57
OG01438.46
OG01525.00
OG0160
OG0170
OG01813.33
OG01935.00
10^-6 threshold MRD
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
Part 1: PF-06863135 1 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG003
Part 1: PF-06863135 3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG004
Part 1: PF-06863135 10 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG005
Part 1: PF-06863135 30 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG006
Part 1: PF-06863135 50 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG007
Part 1: PF-06863135 80 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG008
Part 1: PF-06863135 130 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG009
Part 1: PF-06863135 215 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG010
Part 1: PF-06863135 360 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG011
Part 1: PF-06863135 600 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG012
Part 1: PF-06863135 1000 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG013
Part 1.1: PF-06863135 Priming Cohort Q1W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG014
Part 1.1: PF-06863135 Priming Cohort Q2W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG015
Part 1C: PF-06863135 + Lenalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG016
Part 1D: PF-06863135 + Pomalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Units
Counts
Participants
OG0002
OG0013
OG0022
OG0033
OG0042
OG0055
OG0066
OG0076
OG0084
OG0094
OG0104
OG0116
OG0126
OG0136
OG01412
OG0154
OG0169
Title
Denominators
Categories
Total PF-06863135: Cycle 0 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0136
ParticipantsOG01410
ParticipantsOG0154
ParticipantsOG0168
Title
Measurements
OG0133.639± 21
OG0144.216± 42
OG0152.144± 96
OG016
Total PF-06863135: Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0033
Total PF-06863135: Cycle 2 Day 1
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0032
Free PF-06863135: Cycle 0 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Free PF-06863135: Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0033
Free PF-06863135: Cycle 2 Day 1
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0032
OG002
Part 1: PF-06863135 1 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG003
Part 1: PF-06863135 3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG004
Part 1: PF-06863135 10 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG005
Part 1: PF-06863135 30 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG006
Part 1: PF-06863135 50 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG007
Part 1: PF-06863135 80 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG008
Part 1: PF-06863135 130 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG009
Part 1: PF-06863135 215 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG010
Part 1: PF-06863135 360 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG011
Part 1: PF-06863135 600 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG012
Part 1: PF-06863135 1000 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG013
Part 1.1: PF-06863135 Priming Cohort Q1W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG014
Part 1.1: PF-06863135 Priming Cohort Q2W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG015
Part 1C: PF-06863135 + Lenalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG016
Part 1D: PF-06863135 + Pomalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Units
Counts
Participants
OG0002
OG0013
OG0022
OG0033
OG0042
OG0055
OG0066
OG0076
OG0084
OG0094
OG0104
OG0116
OG0126
OG0136
OG01412
OG0154
OG0169
Title
Denominators
Categories
Total PF-06863135: Cycle 0 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0136
ParticipantsOG01410
ParticipantsOG0153
ParticipantsOG0168
Title
Measurements
OG01316.82± 20
OG01416.93± 46
OG0159.643± 148
OG016
Total PF-06863135: Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0033
Total PF-06863135: Cycle 2 Day 1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0030
Free PF-06863135: Cycle 0 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Free PF-06863135: Cycle 1 Day 1
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG0033
Free PF-06863135: Cycle 2 Day 1
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0032
Units
Counts
Participants
OG0004
OG0019
Title
Denominators
Categories
Cycle 1 Day 1
Title
Measurements
OG000NA(NA to NA)Median, lower limit and upper limit was not estimable as the concentration was below the lower limit of quantification (LLOQ) of 1.00 nanogram per milliliter (ng/mL).
OG001NA(NA to NA)Median, lower limit and upper limit was not estimable as the concentration was below the lower limit of quantification (LLOQ) of 1.00 nanogram per milliliter (ng/mL).
Cycle 1 Day 8
Title
Measurements
OG00070.70(70.7 to 70.7)
OG00113.60(0.000 to 57.8)
Cycle 1 Day 15
Title
Measurements
OG00070.60(70.6 to 70.6)
OG00132.70(0.000 to 49.1)
Cycle 2 Day 15
Title
Measurements
OG00036.70(20.2 to 234)
OG0010.0000(0.000 to 7.41)
OG002
Part 1: PF-06863135 1 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG003
Part 1: PF-06863135 3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG004
Part 1: PF-06863135 10 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG005
Part 1: PF-06863135 30 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG006
Part 1: PF-06863135 50 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG007
Part 1: PF-06863135 80 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG008
Part 1: PF-06863135 130 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG009
Part 1: PF-06863135 215 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG010
Part 1: PF-06863135 360 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG011
Part 1: PF-06863135 600 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG012
Part 1: PF-06863135 1000 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG013
Part 1.1: PF-06863135 Priming Cohort Q1W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG014
Part 1.1: PF-06863135 Priming Cohort Q2W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG015
Part 1C: PF-06863135 + Lenalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG016
Part 1D: PF-06863135 + Pomalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Units
Counts
Participants
OG0002
OG0013
OG0022
OG0033
OG0042
OG0055
OG0066
OG0076
OG0084
OG0094
OG0104
OG0116
OG0126
OG0136
OG01413
OG0154
OG0169
Title
Denominators
Categories
ADA positive
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0052
OG0061
OG0072
OG0081
OG0090
OG0101
OG0110
OG0120
OG0130
OG0141
OG0150
OG0160
NAb positive
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
Part 1: PF-06863135 1 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG003
Part 1: PF-06863135 3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG004
Part 1: PF-06863135 10 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG005
Part 1: PF-06863135 30 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG006
Part 1: PF-06863135 50 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG007
Part 1: PF-06863135 80 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG008
Part 1: PF-06863135 130 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG009
Part 1: PF-06863135 215 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG010
Part 1: PF-06863135 360 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG011
Part 1: PF-06863135 600 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG012
Part 1: PF-06863135 1000 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG013
Part 1.1: PF-06863135 Priming Cohort Q1W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG014
Part 1.1: PF-06863135 Priming Cohort Q2W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG015
Part 1C: PF-06863135 + Lenalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
OG016
Part 1D: PF-06863135 + Pomalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Units
Counts
Participants
OG0002
OG0013
OG0022
OG0033
OG0042
OG0055
OG0066
OG0076
OG0084
OG0094
OG0104
OG0116
OG0126
OG0137
OG01413
OG0154
OG0169
Title
Denominators
Categories
Interleukin-2: Cycle 0; 0 hours
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0137
ParticipantsOG01413
ParticipantsOG0154
ParticipantsOG0168
Title
Measurements
OG0132.10(2.1 to 2.1)
OG0142.10(2.1 to 2.1)
OG0152.10(2.1 to 2.1)
OG016
Interleukin-2: Cycle 0; 2 hours
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Interleukin-2: Cycle 0; 4 hours
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Interleukin-2: Cycle 0; 8 hours
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Interleukin-2: Cycle 0; 24 hours
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Interleukin-2: Cycle 1; 0 hours
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Interleukin-2: Cycle 1; 2 hours
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Interleukin-2: Cycle 1; 4 hours
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Interleukin-2: Cycle 1; 8 hours
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0032
Interleukin-2: Cycle 1; 24 hours
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Interleukin-2: Cycle 1; 72 hours
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Interleukin-6: Cycle 0; 0 hours
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Interleukin-6: Cycle 0; 2 hours
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Interleukin-6: Cycle 0; 4 hours
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Interleukin-6: Cycle 0; 8 hours
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Interleukin-6: Cycle 0; 24 hours
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Interleukin-6: Cycle 1; 0 hours
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Interleukin-6: Cycle 1; 2 hours
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Interleukin-6: Cycle 1; 4 hours
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Interleukin-6: Cycle 1; 8 hours
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0032
Interleukin-6: Cycle 1; 24 hours
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Interleukin-6: Cycle 1; 72 hours
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Interferon-gamma: Cycle 0; 0 hours
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Interferon-gamma: Cycle 0; 2 hours
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Interferon-gamma: Cycle 0; 4 hours
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Interferon-gamma: Cycle 0; 8 hours
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Interferon-gamma: Cycle 0; 24 hours
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Interferon-gamma: Cycle 1; 0 hours
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Interferon-gamma: Cycle 1; 2 hours
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Interferon-gamma: Cycle 1; 4 hours
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Interferon-gamma: Cycle 1; 8 hours
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0032
Interferon-gamma: Cycle 1; 24 hours
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Interferon-gamma: Cycle 1; 72 hours
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Tumor necrosis factor-alpha: Cycle 0; 0 hours
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Tumor necrosis factor-alpha: Cycle 0; 2 hours
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Tumor necrosis factor-alpha: Cycle 0; 4 hours
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Tumor necrosis factor-alpha: Cycle 0; 8 hours
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Tumor necrosis factor-alpha: Cycle 0; 24 hours
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Tumor necrosis factor-alpha: Cycle 1; 0 hours
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Tumor necrosis factor-alpha: Cycle 1; 2 hours
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Tumor necrosis factor-alpha: Cycle 1; 4 hours
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Tumor necrosis factor-alpha: Cycle 1; 8 hours
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0032
Tumor necrosis factor-alpha: Cycle 1; 24 hours
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Tumor necrosis factor-alpha: Cycle 1; 72 hours
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Units
Counts
Participants
OG00015
Title
Denominators
Categories
Participants with TEAEs
Title
Measurements
OG00015
Participants with serious AEs
Title
Measurements
OG00012
Participants with treatment related AEs
Title
Measurements
OG00013
Participants with grade 3 or 4 AEs
Title
Measurements
OG00011
Participants with grade 5 AEs
Title
Measurements
OG0003
Units
Counts
Participants
OG00015
Title
Denominators
Categories
Title
Measurements
OG00015
Units
Counts
Participants
OG00015
Title
Denominators
Categories
Title
Measurements
OG0008
OG00015
Title
Denominators
Categories
Title
Measurements
OG0000
OG000
15
Title
Denominators
Categories
Title
Measurements
OG00033.3(15.2 to 58.3)
Units
Counts
Participants
OG0005
Title
Denominators
Categories
Title
Measurements
OG0009.4(6.5 to NA)Upper limit of 95% CI was not estimable due to insufficient number of participants with event.
Units
Counts
Participants
OG0009
Title
Denominators
Categories
Title
Measurements
OG00040.0(8 to 262)
Units
Counts
Participants
OG00012
Title
Denominators
Categories
Title
Measurements
OG00011.6(1.9 to NA)Upper limit of 95% CI was not estimable due to insufficient number of participants with event.
OG00015
Title
Denominators
Categories
Title
Measurements
OG00010.4(1.2 to 20.0)
15
Title
Denominators
Categories
Title
Measurements
OG00012.1(4.2 to NA)Upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Counts
Participants
OG00015
Title
Denominators
Categories
10^-5 threshold MRD
Title
Measurements
OG00033.33
10^-6 threshold MRD
Title
Measurements
OG00013.33
OG00015
Title
Denominators
Categories
ADA positive
Title
Measurements
OG0000
NAb positive
Title
Measurements
OG0000
OG00015
Title
Denominators
Categories
Interleukin-2: Cycle 0; 0 hours
ParticipantsOG00013
Title
Measurements
OG0002.10(2.1 to 2.1)
Interleukin-2: Cycle 0; 2 hours
ParticipantsOG00013
Title
Measurements
OG0002.10(2.1 to 27.5)
Interleukin-2: Cycle 0; 4 hours
ParticipantsOG00013
Title
Measurements
OG0002.10(2.1 to 48.6)
Interleukin-2: Cycle 0; 8 hours
ParticipantsOG00013
Title
Measurements
OG0002.10(2.1 to 10.6)
Interleukin-2: Cycle 0; 24 hours
ParticipantsOG00012
Title
Measurements
OG0002.10(2.1 to 30.1)
Interleukin-2: Cycle 1; 0 hours
ParticipantsOG00014
Title
Measurements
OG0002.10(2.1 to 2.1)
Interleukin-2: Cycle 1; 2 hours
ParticipantsOG00014
Title
Measurements
OG0002.10(2.1 to 2.1)
Interleukin-2: Cycle 1; 4 hours
ParticipantsOG00014
Title
Measurements
OG0002.10(2.1 to 2.1)
Interleukin-2: Cycle 1; 8 hours
ParticipantsOG00013
Title
Measurements
OG0002.10(2.1 to 3.0)
Interleukin-2: Cycle 1; 24 hours
ParticipantsOG00013
Title
Measurements
OG0002.10(2.1 to 2.1)
Interleukin-2: Cycle 1; 72 hours
ParticipantsOG00013
Title
Measurements
OG0002.10(2.1 to 2.1)
Interleukin-6: Cycle 0; 0 hours
ParticipantsOG00013
Title
Measurements
OG0002.00(2.0 to 63.1)
Interleukin-6: Cycle 0; 2 hours
ParticipantsOG00013
Title
Measurements
OG0002.00(2.0 to 7.0)
Interleukin-6: Cycle 0; 4 hours
ParticipantsOG00013
Title
Measurements
OG0002.00(2.0 to 23.1)
Interleukin-6: Cycle 0; 8 hours
ParticipantsOG00013
Title
Measurements
OG0002.00(2.0 to 9.3)
Interleukin-6: Cycle 0; 24 hours
ParticipantsOG00012
Title
Measurements
OG00010.30(2.0 to 2480.3)
Interleukin-6: Cycle 1; 0 hours
ParticipantsOG00014
Title
Measurements
OG0005.05(2.0 to 156.0)
Interleukin-6: Cycle 1; 2 hours
ParticipantsOG00014
Title
Measurements
OG0002.00(2.0 to 88.6)
Interleukin-6: Cycle 1; 4 hours
ParticipantsOG00014
Title
Measurements
OG0002.30(2.0 to 78.9)
Interleukin-6: Cycle 1; 8 hours
ParticipantsOG00013
Title
Measurements
OG0002.00(2.0 to 53.3)
Interleukin-6: Cycle 1; 24 hours
ParticipantsOG00013
Title
Measurements
OG0003.70(2.0 to 466.7)
Interleukin-6: Cycle 1; 72 hours
ParticipantsOG00013
Title
Measurements
OG0007.50(2.0 to 1231.3)
Interferon-gamma: Cycle 0; 0 hours
ParticipantsOG00013
Title
Measurements
OG0004.20(4.2 to 4.2)
Interferon-gamma: Cycle 0; 2 hours
ParticipantsOG00013
Title
Measurements
OG0004.20(4.2 to 4.2)
Interferon-gamma: Cycle 0; 4 hours
ParticipantsOG00013
Title
Measurements
OG0004.20(4.2 to 4.2)
Interferon-gamma: Cycle 0; 8 hours
ParticipantsOG00013
Title
Measurements
OG0004.20(3.0 to 4.2)
Interferon-gamma: Cycle 0; 24 hours
ParticipantsOG00012
Title
Measurements
OG0004.20(4.2 to 47.3)
Interferon-gamma: Cycle 1; 0 hours
ParticipantsOG00014
Title
Measurements
OG0004.20(4.2 to 4.2)
Interferon-gamma: Cycle 1; 2 hours
ParticipantsOG00014
Title
Measurements
OG0004.20(4.2 to 4.2)
Interferon-gamma: Cycle 1; 4 hours
ParticipantsOG00014
Title
Measurements
OG0004.20(2.2 to 4.2)
Interferon-gamma: Cycle 1; 8 hours
ParticipantsOG00013
Title
Measurements
OG0004.20(4.2 to 4.2)
Interferon-gamma: Cycle 1; 24 hours
ParticipantsOG00013
Title
Measurements
OG0004.20(4.2 to 7.5)
Interferon-gamma: Cycle 1; 72 hours
ParticipantsOG00013
Title
Measurements
OG0004.20(4.2 to 4.2)
Tumor necrosis factor-alpha: Cycle 0; 0 hours
ParticipantsOG00013
Title
Measurements
OG0001.70(1.7 to 2.8)
Tumor necrosis factor-alpha: Cycle 0; 2 hours
ParticipantsOG00013
Title
Measurements
OG0001.70(1.7 to 58.5)
Tumor necrosis factor-alpha: Cycle 0; 4 hours
ParticipantsOG00013
Title
Measurements
OG0001.70(1.7 to 20.8)
Tumor necrosis factor-alpha: Cycle 0; 8 hours
ParticipantsOG00013
Title
Measurements
OG0001.70(1.7 to 3.9)
Tumor necrosis factor-alpha: Cycle 0; 24 hours
ParticipantsOG00012
Title
Measurements
OG0002.55(1.7 to 12.7)
Tumor necrosis factor-alpha: Cycle 1; 0 hours
ParticipantsOG00014
Title
Measurements
OG0001.70(1.7 to 4.9)
Tumor necrosis factor-alpha: Cycle 1; 2 hours
ParticipantsOG00014
Title
Measurements
OG0001.70(1.7 to 5.2)
Tumor necrosis factor-alpha: Cycle 1; 4 hours
ParticipantsOG00014
Title
Measurements
OG0001.70(1.7 to 5.8)
Tumor necrosis factor-alpha: Cycle 1; 8 hours
ParticipantsOG00013
Title
Measurements
OG0001.70(1.7 to 3.6)
Tumor necrosis factor-alpha: Cycle 1; 24 hours
ParticipantsOG00013
Title
Measurements
OG0001.70(1.7 to 5.2)
Tumor necrosis factor-alpha: Cycle 1; 72 hours
ParticipantsOG00013
Title
Measurements
OG0001.70(1.7 to 2.9)
0 affected
3 at risk
EG0040 affected2 at risk
EG0051 affected5 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected6 at risk
EG0121 affected6 at risk
EG0130 affected7 at risk
EG0141 affected13 at risk
EG0150 affected4 at risk
EG0160 affected9 at risk
EG0170 affected15 at risk
EG0181 affected23 at risk
EG0191 affected30 at risk
EG0201 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected6 at risk
EG0120 affected6 at risk
EG0130 affected7 at risk
EG0141 affected13 at risk
EG0150 affected4 at risk
EG0161 affected9 at risk
EG0170 affected15 at risk
EG0180 affected23 at risk
EG0190 affected30 at risk
EG0201 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected4 at risk
EG0091 affected4 at risk
EG0100 affected4 at risk
EG0110 affected6 at risk
EG0120 affected6 at risk
EG0130 affected7 at risk
EG0140 affected13 at risk
EG0150 affected4 at risk
EG0160 affected9 at risk
EG0170 affected15 at risk
EG0180 affected23 at risk
EG0191 affected30 at risk
EG0200 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected6 at risk
EG0120 affected6 at risk
EG0130 affected7 at risk
EG0140 affected13 at risk
EG0150 affected4 at risk
EG0160 affected9 at risk
EG0171 affected15 at risk
EG0180 affected23 at risk
EG0190 affected30 at risk
EG0200 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0081 affected4 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected6 at risk
EG0120 affected6 at risk
EG0130 affected7 at risk
EG0140 affected13 at risk
EG0150 affected4 at risk
EG0160 affected9 at risk
EG0170 affected15 at risk
EG0180 affected23 at risk
EG0191 affected30 at risk
EG0200 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected6 at risk
EG0120 affected6 at risk
EG0130 affected7 at risk
EG0140 affected13 at risk
EG0150 affected4 at risk
EG0160 affected9 at risk
EG0171 affected15 at risk
EG0180 affected23 at risk
EG0190 affected30 at risk
EG0200 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected6 at risk
EG0120 affected6 at risk
EG0130 affected7 at risk
EG0140 affected13 at risk
EG0150 affected4 at risk
EG0160 affected9 at risk
EG0171 affected15 at risk
EG0180 affected23 at risk
EG0190 affected30 at risk
EG0200 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected6 at risk
EG0120 affected6 at risk
EG0130 affected7 at risk
EG0140 affected13 at risk
EG0150 affected4 at risk
EG0160 affected9 at risk
EG0171 affected15 at risk
EG0180 affected23 at risk
EG0190 affected30 at risk
EG0200 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0081 affected4 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected6 at risk
EG0120 affected6 at risk
EG0130 affected7 at risk
EG0140 affected13 at risk
EG0150 affected4 at risk
EG0160 affected9 at risk
EG0170 affected15 at risk
EG0180 affected23 at risk
EG0191 affected30 at risk
EG0200 affected20 at risk
0 affected
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1 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected4 at risk
EG0091 affected4 at risk
EG0101 affected4 at risk
EG0113 affected6 at risk
EG0121 affected6 at risk
EG0133 affected7 at risk
EG0143 affected13 at risk
EG0152 affected4 at risk
EG0165 affected9 at risk
EG0173 affected15 at risk
EG0182 affected23 at risk
EG0196 affected30 at risk
EG0206 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0061 affected6 at risk
EG0071 affected6 at risk
EG0081 affected4 at risk
EG0092 affected4 at risk
EG0101 affected4 at risk
EG0111 affected6 at risk
EG0121 affected6 at risk
EG0132 affected7 at risk
EG0147 affected13 at risk
EG0151 affected4 at risk
EG0163 affected9 at risk
EG0173 affected15 at risk
EG0182 affected23 at risk
EG0197 affected30 at risk
EG0209 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0060 affected6 at risk
EG0071 affected6 at risk
EG0080 affected4 at risk
EG0091 affected4 at risk
EG0100 affected4 at risk
EG0111 affected6 at risk
EG0121 affected6 at risk
EG0130 affected7 at risk
EG0144 affected13 at risk
EG0150 affected4 at risk
EG0161 affected9 at risk
EG0171 affected15 at risk
EG0181 affected23 at risk
EG0194 affected30 at risk
EG0204 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0053 affected5 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected4 at risk
EG0092 affected4 at risk
EG0100 affected4 at risk
EG0112 affected6 at risk
EG0122 affected6 at risk
EG0134 affected7 at risk
EG0144 affected13 at risk
EG0152 affected4 at risk
EG0163 affected9 at risk
EG0176 affected15 at risk
EG0183 affected23 at risk
EG0196 affected30 at risk
EG0208 affected20 at risk
1 affected
3 at risk
EG0042 affected2 at risk
EG0050 affected5 at risk
EG0060 affected6 at risk
EG0072 affected6 at risk
EG0082 affected4 at risk
EG0092 affected4 at risk
EG0101 affected4 at risk
EG0111 affected6 at risk
EG0121 affected6 at risk
EG0131 affected7 at risk
EG0142 affected13 at risk
EG0154 affected4 at risk
EG0162 affected9 at risk
EG0175 affected15 at risk
EG0186 affected23 at risk
EG0199 affected30 at risk
EG0203 affected20 at risk
0 affected
3 at risk
EG0041 affected2 at risk
EG0050 affected5 at risk
EG0062 affected6 at risk
EG0071 affected6 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0111 affected6 at risk
EG0122 affected6 at risk
EG0133 affected7 at risk
EG0145 affected13 at risk
EG0151 affected4 at risk
EG0163 affected9 at risk
EG0175 affected15 at risk
EG0184 affected23 at risk
EG0194 affected30 at risk
EG0208 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0060 affected6 at risk
EG0071 affected6 at risk
EG0080 affected4 at risk
EG0091 affected4 at risk
EG0100 affected4 at risk
EG0111 affected6 at risk
EG0120 affected6 at risk
EG0130 affected7 at risk
EG0141 affected13 at risk
EG0150 affected4 at risk
EG0162 affected9 at risk
EG0171 affected15 at risk
EG0180 affected23 at risk
EG0193 affected30 at risk
EG0201 affected20 at risk
1 affected
3 at risk
EG0040 affected2 at risk
EG0052 affected5 at risk
EG0060 affected6 at risk
EG0071 affected6 at risk
EG0080 affected4 at risk
EG0091 affected4 at risk
EG0100 affected4 at risk
EG0110 affected6 at risk
EG0120 affected6 at risk
EG0130 affected7 at risk
EG0140 affected13 at risk
EG0151 affected4 at risk
EG0161 affected9 at risk
EG0172 affected15 at risk
EG0184 affected23 at risk
EG0192 affected30 at risk
EG0200 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0051 affected5 at risk
EG0061 affected6 at risk
EG0070 affected6 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0101 affected4 at risk
EG0110 affected6 at risk
EG0120 affected6 at risk
EG0132 affected7 at risk
EG0143 affected13 at risk
EG0150 affected4 at risk
EG0162 affected9 at risk
EG0170 affected15 at risk
EG0183 affected23 at risk
EG0191 affected30 at risk
EG0205 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0081 affected4 at risk
EG0091 affected4 at risk
EG0100 affected4 at risk
EG0111 affected6 at risk
EG0121 affected6 at risk
EG0130 affected7 at risk
EG0140 affected13 at risk
EG0151 affected4 at risk
EG0162 affected9 at risk
EG0170 affected15 at risk
EG0180 affected23 at risk
EG0194 affected30 at risk
EG0200 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0060 affected6 at risk
EG0071 affected6 at risk
EG0080 affected4 at risk
EG0092 affected4 at risk
EG0101 affected4 at risk
EG0112 affected6 at risk
EG0122 affected6 at risk
EG0131 affected7 at risk
EG0145 affected13 at risk
EG0151 affected4 at risk
EG0162 affected9 at risk
EG0172 affected15 at risk
EG0180 affected23 at risk
EG0198 affected30 at risk
EG0206 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0051 affected5 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected6 at risk
EG0123 affected6 at risk
EG0130 affected7 at risk
EG0140 affected13 at risk
EG0150 affected4 at risk
EG0162 affected9 at risk
EG0171 affected15 at risk
EG0181 affected23 at risk
EG0193 affected30 at risk
EG0200 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0051 affected5 at risk
EG0062 affected6 at risk
EG0070 affected6 at risk
EG0080 affected4 at risk
EG0091 affected4 at risk
EG0100 affected4 at risk
EG0111 affected6 at risk
EG0120 affected6 at risk
EG0130 affected7 at risk
EG0142 affected13 at risk
EG0151 affected4 at risk
EG0162 affected9 at risk
EG0171 affected15 at risk
EG0183 affected23 at risk
EG0192 affected30 at risk
EG0202 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0062 affected6 at risk
EG0070 affected6 at risk
EG0080 affected4 at risk
EG0092 affected4 at risk
EG0100 affected4 at risk
EG0110 affected6 at risk
EG0124 affected6 at risk
EG0130 affected7 at risk
EG0144 affected13 at risk
EG0152 affected4 at risk
EG0164 affected9 at risk
EG0171 affected15 at risk
EG0183 affected23 at risk
EG0196 affected30 at risk
EG0204 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0101 affected4 at risk
EG0111 affected6 at risk
EG0122 affected6 at risk
EG0132 affected7 at risk
EG0141 affected13 at risk
EG0150 affected4 at risk
EG0160 affected9 at risk
EG0171 affected15 at risk
EG0180 affected23 at risk
EG0194 affected30 at risk
EG0203 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected6 at risk
EG0121 affected6 at risk
EG0131 affected7 at risk
EG0142 affected13 at risk
EG0150 affected4 at risk
EG0160 affected9 at risk
EG0172 affected15 at risk
EG0180 affected23 at risk
EG0191 affected30 at risk
EG0203 affected20 at risk
1 affected
3 at risk
EG0040 affected2 at risk
EG0051 affected5 at risk
EG0061 affected6 at risk
EG0070 affected6 at risk
EG0081 affected4 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected6 at risk
EG0120 affected6 at risk
EG0130 affected7 at risk
EG0141 affected13 at risk
EG0150 affected4 at risk
EG0160 affected9 at risk
EG0170 affected15 at risk
EG0184 affected23 at risk
EG0191 affected30 at risk
EG0201 affected20 at risk
1 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0061 affected6 at risk
EG0071 affected6 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0101 affected4 at risk
EG0110 affected6 at risk
EG0121 affected6 at risk
EG0131 affected7 at risk
EG0142 affected13 at risk
EG0151 affected4 at risk
EG0160 affected9 at risk
EG0172 affected15 at risk
EG0183 affected23 at risk
EG0193 affected30 at risk
EG0203 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0051 affected5 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0111 affected6 at risk
EG0120 affected6 at risk
EG0130 affected7 at risk
EG0141 affected13 at risk
EG0150 affected4 at risk
EG0160 affected9 at risk
EG0173 affected15 at risk
EG0181 affected23 at risk
EG0191 affected30 at risk
EG0201 affected20 at risk
1 affected
3 at risk
EG0041 affected2 at risk
EG0051 affected5 at risk
EG0060 affected6 at risk
EG0071 affected6 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0112 affected6 at risk
EG0122 affected6 at risk
EG0131 affected7 at risk
EG0144 affected13 at risk
EG0152 affected4 at risk
EG0164 affected9 at risk
EG0172 affected15 at risk
EG0183 affected23 at risk
EG0195 affected30 at risk
EG0205 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0061 affected6 at risk
EG0071 affected6 at risk
EG0082 affected4 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected6 at risk
EG0121 affected6 at risk
EG0131 affected7 at risk
EG0146 affected13 at risk
EG0150 affected4 at risk
EG0161 affected9 at risk
EG0172 affected15 at risk
EG0181 affected23 at risk
EG0194 affected30 at risk
EG0207 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected4 at risk
EG0091 affected4 at risk
EG0100 affected4 at risk
EG0111 affected6 at risk
EG0120 affected6 at risk
EG0130 affected7 at risk
EG0142 affected13 at risk
EG0150 affected4 at risk
EG0162 affected9 at risk
EG0170 affected15 at risk
EG0180 affected23 at risk
EG0192 affected30 at risk
EG0202 affected20 at risk
1 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0060 affected6 at risk
EG0071 affected6 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected6 at risk
EG0120 affected6 at risk
EG0130 affected7 at risk
EG0142 affected13 at risk
EG0150 affected4 at risk
EG0161 affected9 at risk
EG0171 affected15 at risk
EG0181 affected23 at risk
EG0191 affected30 at risk
EG0202 affected20 at risk
1 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0110 affected6 at risk
EG0121 affected6 at risk
EG0130 affected7 at risk
EG0140 affected13 at risk
EG0152 affected4 at risk
EG0162 affected9 at risk
EG0170 affected15 at risk
EG0182 affected23 at risk
EG0191 affected30 at risk
EG0200 affected20 at risk
1 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0101 affected4 at risk
EG0111 affected6 at risk
EG0120 affected6 at risk
EG0131 affected7 at risk
EG0140 affected13 at risk
EG0150 affected4 at risk
EG0160 affected9 at risk
EG0172 affected15 at risk
EG0181 affected23 at risk
EG0192 affected30 at risk
EG0201 affected20 at risk
2 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected4 at risk
EG0091 affected4 at risk
EG0101 affected4 at risk
EG0111 affected6 at risk
EG0120 affected6 at risk
EG0130 affected7 at risk
EG0142 affected13 at risk
EG0151 affected4 at risk
EG0162 affected9 at risk
EG0170 affected15 at risk
EG0183 affected23 at risk
EG0193 affected30 at risk
EG0202 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected4 at risk
EG0091 affected4 at risk
EG0101 affected4 at risk
EG0113 affected6 at risk
EG0122 affected6 at risk
EG0133 affected7 at risk
EG0144 affected13 at risk
EG0154 affected4 at risk
EG0163 affected9 at risk
EG0176 affected15 at risk
EG0180 affected23 at risk
EG0197 affected30 at risk
EG0207 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0051 affected5 at risk
EG0060 affected6 at risk
EG0071 affected6 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0100 affected4 at risk
EG0112 affected6 at risk
EG0122 affected6 at risk
EG0131 affected7 at risk
EG0142 affected13 at risk
EG0152 affected4 at risk
EG0160 affected9 at risk
EG0172 affected15 at risk
EG0181 affected23 at risk
EG0195 affected30 at risk
EG0203 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0051 affected5 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected4 at risk
EG0091 affected4 at risk
EG0100 affected4 at risk
EG0111 affected6 at risk
EG0120 affected6 at risk
EG0130 affected7 at risk
EG0142 affected13 at risk
EG0151 affected4 at risk
EG0161 affected9 at risk
EG0171 affected15 at risk
EG0181 affected23 at risk
EG0192 affected30 at risk
EG0202 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0101 affected4 at risk
EG0111 affected6 at risk
EG0122 affected6 at risk
EG0130 affected7 at risk
EG0141 affected13 at risk
EG0151 affected4 at risk
EG0160 affected9 at risk
EG0172 affected15 at risk
EG0180 affected23 at risk
EG0194 affected30 at risk
EG0201 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0080 affected4 at risk
EG0090 affected4 at risk
EG0103 affected4 at risk
EG0111 affected6 at risk
EG0121 affected6 at risk
EG0130 affected7 at risk
EG0142 affected13 at risk
EG0150 affected4 at risk
EG0162 affected9 at risk
EG0171 affected15 at risk
EG0180 affected23 at risk
EG0195 affected30 at risk
EG0202 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0051 affected5 at risk
EG0060 affected6 at risk
EG0070 affected6 at risk
EG0081 affected4 at risk
EG0091 affected4 at risk
EG0100 affected4 at risk
EG0111 affected6 at risk
EG0120 affected6 at risk
EG0131 affected7 at risk
EG0141 affected13 at risk
EG0150 affected4 at risk
EG0161 affected9 at risk
EG0172 affected15 at risk
EG0182 affected23 at risk
EG0193 affected30 at risk
EG0202 affected20 at risk
0 affected
3 at risk
EG0040 affected2 at risk
EG0050 affected5 at risk
EG0061 affected6 at risk
EG0070 affected6 at risk
EG0081 affected4 at risk
EG0091 affected4 at risk
EG0100 affected4 at risk
EG0112 affected6 at risk
EG0121 affected6 at risk
EG0130 affected7 at risk
EG0140 affected13 at risk
EG0150 affected4 at risk
EG0162 affected9 at risk
EG0172 affected15 at risk
EG0181 affected23 at risk
EG0195 affected30 at risk
EG0200 affected20 at risk
3
OG0040
OG0052
OG0065
OG0074
OG0081
OG0093
OG0103
OG0114
OG0125
OG0136
OG0149
OG0152
OG0168
OG01711
OG01820
OG01915
1
OG0042
OG0054
OG0066
OG0074
OG0084
OG0094
OG0104
OG0116
OG0126
OG0137
OG01413
OG0154
OG0169
OG01717
OG01828
OG01920
2
OG0042
OG0053
OG0066
OG0073
OG0084
OG0093
OG0104
OG0114
OG0126
OG0133
OG01412
OG0154
OG0167
OG01717
OG01824
OG01915
1
OG0040
OG0051
OG0060
OG0073
OG0080
OG0091
OG0100
OG0112
OG0120
OG0133
OG0141
OG0150
OG0162
OG0172
OG0186
OG0194
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG00925.00
OG0100
OG01116.67
OG01216.67
OG0130
OG01430.77
OG0150
OG0160
OG0170
OG01810.00
OG01920.00
2.277
± 51
ParticipantsOG0042
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG0076
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG0104
ParticipantsOG0116
ParticipantsOG0126
ParticipantsOG0136
ParticipantsOG01411
ParticipantsOG0154
ParticipantsOG0169
Title
Measurements
OG000NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.00168 and 0.00282.
OG001NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.00287 and 0.00439
OG002NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.0122 and 0.0133.
OG0030.05363± 36
OG004NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.164 and 0.297.
OG0050.6044± 27
OG0060.8725± 41
OG0070.2866± 46
OG0080.9076± 24
OG0091.220± 25
OG0102.568± 42
OG0113.802± 12
OG0123.620± 53
OG0139.927± 18
OG0148.710± 54
OG0155.513± 141
OG0165.814± 36
ParticipantsOG0041
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0075
ParticipantsOG0084
ParticipantsOG0093
ParticipantsOG0104
ParticipantsOG0116
ParticipantsOG0126
ParticipantsOG0134
ParticipantsOG0144
ParticipantsOG0151
ParticipantsOG0162
Title
Measurements
OG001NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.475 and 0.624.
OG002NASince only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.219.
OG003NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.151 and 0.233.
OG004NASince only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.440.
OG0050.9924± 8
OG0061.684± 23
OG0070.6904± 55
OG0082.108± 38
OG0093.021± 24
OG0105.748± 16
OG01111.92± 28
OG01212.98± 26
OG01325.74± 19
OG01412.03± 67
OG015NASince only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 16.6.
OG016NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 10.8 and 12.0.
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0136
ParticipantsOG01410
ParticipantsOG0154
ParticipantsOG0169
Title
Measurements
OG0130.9445± 59
OG0141.087± 79
OG0150.5165± 83
OG0160.8080± 59
ParticipantsOG0042
ParticipantsOG0055
ParticipantsOG0066
ParticipantsOG0076
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG0104
ParticipantsOG0116
ParticipantsOG0126
ParticipantsOG0136
ParticipantsOG01411
ParticipantsOG0154
ParticipantsOG0169
Title
Measurements
OG000NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.
OG001NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.
OG002NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.
OG0030.0008828± 1.23
OG004NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.0760 and 0.153.
OG0050.1851± 40
OG0060.3015± 75
OG0070.09913± 36
OG0080.2479± 28
OG0090.5916± 47
OG0100.8304± 131
OG0110.9875± 52
OG0120.8266± 66
OG0132.088± 106
OG0142.485± 91
OG0151.185± 90
OG0162.150± 76
ParticipantsOG0041
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0075
ParticipantsOG0084
ParticipantsOG0093
ParticipantsOG0104
ParticipantsOG0116
ParticipantsOG0126
ParticipantsOG0134
ParticipantsOG0144
ParticipantsOG0151
ParticipantsOG0162
Title
Measurements
OG001NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.
OG002NASince only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.000.
OG003NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.
OG004NA± NASince only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.103.
OG0050.2855± 37
OG0060.2955± 4
OG0070.1794± 40
OG0080.3998± 41
OG0091.473± 79
OG0101.605± 182
OG0117.981± 79
OG0123.953± 156
OG01311.00± 186
OG0145.323± 69
OG015NASince only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 2.53.
OG016NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 9.65 and 12.1.
10.91
± 37
ParticipantsOG0042
ParticipantsOG0055
ParticipantsOG0065
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0092
ParticipantsOG0104
ParticipantsOG0116
ParticipantsOG0124
ParticipantsOG0135
ParticipantsOG0148
ParticipantsOG0153
ParticipantsOG0166
Title
Measurements
OG000NASince only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.00829.
OG001NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.00933 and 0.0136.
OG002NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.0483 and 0.0484.
OG0030.1654± 74
OG004NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.763 and 0.877.
OG0052.190± 11
OG0063.322± 40
OG0071.182± 58
OG0084.426± 17
OG009NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 4.35 and 6.09.
OG01012.58± 26
OG01117.92± 29
OG01225.53± 36
OG01358.93± 14
OG01493.96± 53
OG01554.78± 16
OG01631.92± 45
ParticipantsOG0040
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0072
ParticipantsOG0084
ParticipantsOG0090
ParticipantsOG0102
ParticipantsOG0116
ParticipantsOG0124
ParticipantsOG0133
ParticipantsOG0144
ParticipantsOG0150
ParticipantsOG0162
Title
Measurements
OG001NASince only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.0276.
OG002NASince only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.0790.
OG005NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 3.88 and 4.36.
OG006NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 7.91 and 8.10.
OG007NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 3.77 and 10.1.
OG00813.47± 39
OG010NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 32.2 and 42.2.
OG01176.83± 30
OG01288.92± 31
OG013173.4± 21
OG014148.1± 65
OG016NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 71.7 and 77.8.
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0136
ParticipantsOG01410
ParticipantsOG0153
ParticipantsOG0168
Title
Measurements
OG0134.111± 49
OG0145.054± 73
OG0152.447± 92
OG0163.487± 50
ParticipantsOG0042
ParticipantsOG0055
ParticipantsOG0065
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0092
ParticipantsOG0104
ParticipantsOG0116
ParticipantsOG0124
ParticipantsOG0135
ParticipantsOG0148
ParticipantsOG0153
ParticipantsOG0166
Title
Measurements
OG000NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.
OG001NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.
OG002NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.
OG0030.0009462± 1.95
OG004NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.261 and 0.618.
OG0050.7801± 24
OG0061.206± 62
OG0070.3344± 72
OG0081.478± 23
OG009NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 2.67 and 3.29.
OG0104.362± 103
OG0114.909± 42
OG0126.564± 33
OG01311.92± 109
OG01434.13± 60
OG0158.896± 12
OG01611.40± 91
ParticipantsOG0041
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0072
ParticipantsOG0084
ParticipantsOG0090
ParticipantsOG0102
ParticipantsOG0116
ParticipantsOG0124
ParticipantsOG0133
ParticipantsOG0144
ParticipantsOG0150
ParticipantsOG0162
Title
Measurements
OG001NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.
OG002NASince only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.000.
OG003NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.
OG004NASince only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.000.
OG0050.05280± 2.59
OG006NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 1.51 and 1.57.
OG007NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 2.15.
OG0082.572± 49
OG010NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 4.43 and 6.57.
OG01145.14± 113
OG01234.18± 155
OG01345.63± 128
OG01466.20± 63
OG016NA± NASince there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 64.2 and 71.2.