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The purpose of this study is to confirm the safety and tolerability of elranatamab (PF-06863135) in Japanese participants with relapsed or refractory MM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elranatamab (PF-06863135) | Experimental | BCMA-CD3 bispecific antibody |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elranatamab (PF-06863135) | Drug | BCMA-CD3 bispecific antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | DLT was defined as any of the following: Treatment Emergent Adverse Events (AEs) occurring in Cycle 0 and Cycle 1 (total 4 weeks): Grade (G) 4 neutropenia lasting greater than (>)7 days; febrile neutropenia (absolute neutrophil count [ANC] less than (<)1,000 per millimeter cube (/mm^3) with single temperature >38.3 degree Celsius (deg C), or sustained temperature of greater than or equal to (>=) 38deg C for >1 hour [h]); G>=3 neutropenia with infection; G4 thrombocytopenia (unless the baseline count was >=25,000/mm^3 and <50,000/mm^3, in which case G4 thrombocytopenia was to be accompanied by >=G2 bleeding), Platelet count <10,000/mm^3 was considered a DLT irrespective of other factors; G3 thrombocytopenia with >=G2 bleeding; G4 AEs; G3 AE >=5 days despite optimal supportive care (except AEs attributed to cytokine release syndrome [CRS]); G3 CRS (except CRS that have not been maximally treated or improved to <=G1 within 48h); confirmed drug induced liver injury. | Up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Emergent Treatment Related AEs and Treatment Emergent Treatment Related SAEs | An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious adverse events. An SAE was defined as any untoward medical occurrence that, at any dose resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event. A TEAE was defined as an AE that first occurred from the first dose of the study intervention until 90 days after the last dose or the day before starting a new anticancer therapy, whichever occurred first. Treatment related AEs and SAEs were defined as AEs and SAEs which was related to the treatment. |
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Inclusion Criteria:
Diagnosis of multiple myeloma (IMWG criteria)
Measurable disease, as defined by at least 1 of the following
Participants must have progressed on or been intolerant of at least 3 prior therapies including proteasome inhibitor, IMID drug and anti-CD38 antibody, either in combination or as a single agent
ECOG PS 0, 1 or 2. PS 3 is permitted if PS is due solely to bone pain
Adequate bone marrow, hematological, kidney and liver function
Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1
Not pregnant and willing to use contraception
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya City University Hospital | Nagoya | Aichi-ken | 467-8602 | Japan | ||
| Japanese Red Cross Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42287565 | Derived | 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. | |
| 40826257 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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A total of 4 participants were screened and assigned to study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Elranatamab | Participants received an initial priming dose of 600 microgram per kilogram elranatamab subcutaneously on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1). During treatment cycle, participants were administered 1000 microgram per kilogram elranatamab weekly during each cycle (each cycle was of 3 weeks). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Safety Analysis Set (SAS) included all enrolled participants who received at least 1 dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Elranatamab | Participants received an initial priming dose of 600 microgram per kilogram elranatamab subcutaneously on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1). During treatment cycle, participants were administered 1000 microgram per kilogram elranatamab weekly during each cycle (each cycle was of 3 weeks). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Dose Limiting Toxicities (DLTs) | DLT was defined as any of the following: Treatment Emergent Adverse Events (AEs) occurring in Cycle 0 and Cycle 1 (total 4 weeks): Grade (G) 4 neutropenia lasting greater than (>)7 days; febrile neutropenia (absolute neutrophil count [ANC] less than (<)1,000 per millimeter cube (/mm^3) with single temperature >38.3 degree Celsius (deg C), or sustained temperature of greater than or equal to (>=) 38deg C for >1 hour [h]); G>=3 neutropenia with infection; G4 thrombocytopenia (unless the baseline count was >=25,000/mm^3 and <50,000/mm^3, in which case G4 thrombocytopenia was to be accompanied by >=G2 bleeding), Platelet count <10,000/mm^3 was considered a DLT irrespective of other factors; G3 thrombocytopenia with >=G2 bleeding; G4 AEs; G3 AE >=5 days despite optimal supportive care (except AEs attributed to cytokine release syndrome [CRS]); G3 CRS (except CRS that have not been maximally treated or improved to <=G1 within 48h); confirmed drug induced liver injury. | Per Protocol Analysis Set included all enrolled participants who had at least 1 dose of study intervention and either experienced DLT or did not have major treatment deviations during the DLT observation period. | Posted | Count of Participants | Participants | Up to 4 weeks |
From first dose of study intervention and up to 90 days after last dose or start of new anticancer therapy (maximum of 65.1 weeks of treatment)
Same event may appear as both SAE and non-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 evaluated. All-Cause Mortality: the total number of deaths during study, from first dose and up to the end of the study are reported for all treated participants and includes deaths which occurred after 90 days post last dose of study intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Elranatamab | Participants received an initial priming dose of 600 microgram per kilogram elranatamab subcutaneously on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1). During treatment cycle, participants were administered 1000 microgram per kilogram elranatamab weekly during each cycle (each cycle was of 3 weeks). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
Due to character limitation in outcome measure(OM)description, expanded form for ICANS, ASTCT, ICE is provided here. Immune Effector Cell-Associated Neurotoxicity, American Society for Transplantation and Cellular Therapy, Immune Effector Cell-Associated Encephalopathy respectively.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 10, 2021 | May 25, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 28, 2022 | May 25, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
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| From first dose of study intervention and up to 90 days after last dose or start of new anticancer therapy (maximum of 65.1 weeks of treatment) |
| Number of Participants With Grade 3 or 4, Grade 5 TEAEs and Treatment Related TEAEs Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Except for CRS and ICANS Graded According to ASTCT Grading Criteria 2019 | CTCAEv5.0 G3:severe/clinically significant;G4:life-threatening;G5:death.ASTCT CRS G3:temp>=38degC,hypotension required vasopressor with/without vasopressin and/or hypoxia required high-flow nasal cannula,facemask,nonrebreather mask or venturi mask;G4:temp>=38degC,hypotension required multiple vasopressors(excluding vasopressin)and/or hypoxia required positive pressure;G5:death.ICANS G3:ICE score0-2,awakens only to tactile stimulus,clinical seizure focal/generalized resolves rapidly or nonconvulsive seizures on electroencephalography resolve with intervention,focal/local edema on neuroimaging;G4:ICEscore 0(unarousable unable to perform ICE),unarousable or requires vigorous/repetitive tactile stimuli to arouse,stupor/coma,life-threatening prolonged seizure(>5 min),repetitive clinical/electrical seizure without return to baseline,deep focal motor weakness,diffuse cerebral edema on neuroimaging,decerebrate/decorticate posturing,cranial nerve VI palsy,papilledema,Cushing's triad;G5:death. | From first dose of study intervention and up to 90 days after last dose or start of new anticancer therapy (maximum of 65.1 weeks of treatment) |
| Number of Participants With Shift From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post -Baseline in Hematology Parameters by NCI CTCAE v 5.0 | Hematology parameters that were assessed included: Anemia, Lymphocyte count decreased, Neutrophil count decreased, Platelet count decreased, White blood cell decreased. Abnormalities were graded based on National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 - Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening. | From first dose of study intervention and up to 90 days after last dose or start of new anticancer therapy (maximum of 65.1 weeks of treatment) |
| Number of Participants With Shift From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post -Baseline in Chemistry Parameters by NCI CTCAE v 5.0 | Chemistry parameters that were assessed included: Alanine aminotransferase increased, Alkaline phosphatase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Creatinine increased, Hypercalcemia, Hyperkalemia, Hypermagnesemia, Hypernatremia, Hypoalbuminemia, Hypocalcemia, Hypoglycemia, Hypokalemia, Hypomagnesemia, Hyponatremia. Abnormalities were graded based on CTCAE version 5.0- Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening. | From first dose of study intervention and up to 90 days after last dose or start of new anticancer therapy (maximum of 65.1 weeks of treatment) |
| Maximum Observed Serum Concentration (Cmax) of Elranatamab | Cycle 0: from Cycle 0 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days]; Cycle 1: from Cycle 1 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days] |
| Time to Maximum Concentration (Tmax) of Elranatamab | Cycle 0: from Cycle 0 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days]; Cycle 1: from Cycle 1 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days] |
| Area Under the Concentration-time Profile From Time Zero to the Time Tau (AUCtau) of Elranatamab | Area under the concentration-time profile from time zero to the time tau where the dosing interval (tau = 1 week). AUCtau was determined using the linear/log trapezoidal method. | Cycle 0: from Cycle 0 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days]; Cycle 1: from Cycle 1 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days] |
| Pre-dose Trough Serum Concentrations After Multiple Doses of Elranatamab | At pre-dose on Day 1 of Cycle 0, 3, 4, 5, 6, 7, 8, 12, 16; at pre-dose on Days 1, 8, 15 of Cycle 1 and 2 |
| Number of Participants With Anti-drug Antibodies (ADA) of Elranatamab | 'A participant was considered ADA positive if baseline titer was missing or negative and participant had >=1 post-treatment positive titer, or positive titer at baseline and had a >=4-fold increase in titer from baseline in >=1 post-treatment sample. | From the date of first dose up to maximum of 65.1 weeks of treatment |
| Titers of ADA | Titers of ADA at specified timepoints were reported in this outcome measure. | Cycle1 Day1, Cycle1 Day15, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1, Cycle6 Day1, Cycle8 Day1, Cycle12 Day1, Cycle16 Day1, End of treatment (maximum of 65.1 weeks of treatment) |
| Number of Participants With Neutralizing Antibodies (NAb) | A participant was considered NAb positive if baseline titer was missing or negative and participant had >=1 post-treatment positive titer, or positive titer at baseline and had a >=4-fold increase in titer from baseline in >=1 post-treatment sample. | From the date of first dose up to maximum of 65.1 weeks of treatment |
| Objective Response Rate (ORR): Percentage of Participants With Objective Response | ORR:% of participants with best overall response; confirmed stringent complete response(sCR),CR, very good partial response(VGPR) or PR per International Myeloma Working Group criteria.sCR: CR& normal serum free light chain(sFLC)ratio &absence of clonal cells in BMB/BMA by immunohistochemistry, immunofluorescence or flow cytometry.CR: negative immunofixation on serum &urine, disappearance of soft tissue plasmacytoma &<5% plasma cells in BMA, if disease measured by sFLC only,preceding criteria plus normal sFLC ratio.VGPR:Serum & urine M-protein detectable by immunofixation but not on electrophoresis; or >=90% reduction in serum&urine M-protein level <100mg/24h.PR:>=50% reduction in serum M-protein & reduction in 24h urinary M-protein by >=90% or <200 mg/24h. If serum & urine M-protein unmeasurable,VGPR & PR: >=90% &>=50% decrease in difference respectively between involved & uninvolved sFLC levels & if present at baseline,>=90% & >=50% reduction in soft tissue plasmacytomas' size. | From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (maximum of 65.1 weeks of treatment) |
| Time to Response (TTR) | TTR was defined for participants with confirmed objective response (sCR,CR,VGPR and PR) as the time from first date of study intervention to the date of first documentation of objective response. sCR: CR and normal sFLC ratio with absence of clonal cells in BMB/BMA by immunohistochemistry, immunofluorescence or flow cytometry.CR: negative immunofixation on serum and urine,disappearance of soft tissue plasmacytoma, <5% plasma cells in BMA, if disease measured by sFLC only,preceding criteria plus normal sFLC ratio.VGPR:Serum and urine M-protein detectable by immunofixation but not on electrophoresis; or >=90% reduction in serum and urine M-protein level <100mg/24h.PR:>=50% reduction in serum M-protein and reduction in 24h urinary M-protein by >=90% or <200 mg/24h.If serum and urine M-protein unmeasurable,VGPR & PR: >=90%,>=50% decrease in difference respectively between involved and uninvolved sFLC levels,if present at baseline,>=90%, >=50% reduction in soft tissue plasmacytomas' size. | From date of first dose to the first documentation of objective response that is subsequently confirmed (maximum of 65.1 weeks of treatment) |
| Duration of Response (DOR) | DOR: time from first documentation of objective response subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease. | From first documentation of objective response subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurs first, or censoring date (maximum of 65.1 weeks of treatment) |
| Progression Free Survival (PFS) | Progression free survival (PFS) was the time from the first date of the study intervention to the date of the first documentation of confirmed progression, or death due to any cause. | From date of first dose until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurs first, or censoring date (maximum of 65.1 weeks of treatment) |
| Overall Survival (OS) | Overall survival (OS) was the time from the first date of the study intervention to the date of death due to any cause. Participants not known to have died are censored on the date of last known alive. | From the date of first dose until death due to any cause or censoring date (maximum of 65.1 weeks of treatment) |
| Minimal Residual Disease (MRD) Negativity Rate | MRD negativity rate was defined as percentage of participants with CR or sCR with negative MRD per IMWG sequencing criteria by bone marrow aspirate (BMA). sCR: CR and normal sFLC ratio with absence of clonal cells in BMB/BMA by immunohistochemistry, immunofluorescence or flow cytometry.CR: negative immunofixation on serum and urine, disappearance of soft tissue plasmacytoma and <5% plasma cells in BMA, if disease measured by sFLC only, preceding criteria plus normal sFLC ratio. MRD was reported at threshold frequency of 10^5 and 10^6. | From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (maximum of 65.1 weeks of treatment) |
| Shibuya-ku |
| Tokyo |
| 150-8935 |
| Japan |
| 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. |
| 40000533 | Derived | 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. |
| 38794892 | Derived | Iida S, Ito S, Yokoyama H, Ishida T, Nagai Y, Handa H, Ito S, Kamei Y, Nakamura M, Suzuki K. Elranatamab in Japanese patients with relapsed/refractory multiple myeloma: results from MagnetisMM-2 and MagnetisMM-3. Jpn J Clin Oncol. 2024 Sep 4;54(9):991-1000. doi: 10.1093/jjco/hyae068. |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Elranatamab | Participants received an initial priming dose of 600 microgram per kilogram elranatamab subcutaneously on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1). During treatment cycle, participants were administered 1000 microgram per kilogram elranatamab weekly during each cycle (each cycle was of 3 weeks). |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Emergent Treatment Related AEs and Treatment Emergent Treatment Related SAEs | An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious adverse events. An SAE was defined as any untoward medical occurrence that, at any dose resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event. A TEAE was defined as an AE that first occurred from the first dose of the study intervention until 90 days after the last dose or the day before starting a new anticancer therapy, whichever occurred first. Treatment related AEs and SAEs were defined as AEs and SAEs which was related to the treatment. | SAS included all enrolled participants who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From first dose of study intervention and up to 90 days after last dose or start of new anticancer therapy (maximum of 65.1 weeks of treatment) |
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| Secondary | Number of Participants With Grade 3 or 4, Grade 5 TEAEs and Treatment Related TEAEs Based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Except for CRS and ICANS Graded According to ASTCT Grading Criteria 2019 | CTCAEv5.0 G3:severe/clinically significant;G4:life-threatening;G5:death.ASTCT CRS G3:temp>=38degC,hypotension required vasopressor with/without vasopressin and/or hypoxia required high-flow nasal cannula,facemask,nonrebreather mask or venturi mask;G4:temp>=38degC,hypotension required multiple vasopressors(excluding vasopressin)and/or hypoxia required positive pressure;G5:death.ICANS G3:ICE score0-2,awakens only to tactile stimulus,clinical seizure focal/generalized resolves rapidly or nonconvulsive seizures on electroencephalography resolve with intervention,focal/local edema on neuroimaging;G4:ICEscore 0(unarousable unable to perform ICE),unarousable or requires vigorous/repetitive tactile stimuli to arouse,stupor/coma,life-threatening prolonged seizure(>5 min),repetitive clinical/electrical seizure without return to baseline,deep focal motor weakness,diffuse cerebral edema on neuroimaging,decerebrate/decorticate posturing,cranial nerve VI palsy,papilledema,Cushing's triad;G5:death. | SAS included all enrolled participants who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From first dose of study intervention and up to 90 days after last dose or start of new anticancer therapy (maximum of 65.1 weeks of treatment) |
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| Secondary | Number of Participants With Shift From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post -Baseline in Hematology Parameters by NCI CTCAE v 5.0 | Hematology parameters that were assessed included: Anemia, Lymphocyte count decreased, Neutrophil count decreased, Platelet count decreased, White blood cell decreased. Abnormalities were graded based on National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 - Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening. | SAS included all enrolled participants who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From first dose of study intervention and up to 90 days after last dose or start of new anticancer therapy (maximum of 65.1 weeks of treatment) |
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| Secondary | Number of Participants With Shift From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post -Baseline in Chemistry Parameters by NCI CTCAE v 5.0 | Chemistry parameters that were assessed included: Alanine aminotransferase increased, Alkaline phosphatase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Creatinine increased, Hypercalcemia, Hyperkalemia, Hypermagnesemia, Hypernatremia, Hypoalbuminemia, Hypocalcemia, Hypoglycemia, Hypokalemia, Hypomagnesemia, Hyponatremia. Abnormalities were graded based on CTCAE version 5.0- Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening. | SAS included all enrolled participants who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From first dose of study intervention and up to 90 days after last dose or start of new anticancer therapy (maximum of 65.1 weeks of treatment) |
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| Secondary | Maximum Observed Serum Concentration (Cmax) of Elranatamab | Pharmacokinetic parameter analysis population was defined as all enrolled participants treated who did not have protocol deviations influencing PK assessment and had sufficient information to estimate at least 1 of the PK parameters of interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | Cycle 0: from Cycle 0 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days]; Cycle 1: from Cycle 1 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days] |
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| Secondary | Time to Maximum Concentration (Tmax) of Elranatamab | Pharmacokinetic parameter analysis population was defined as all enrolled participants treated who did not have protocol deviations influencing PK assessment and had sufficient information to estimate at least 1 of the PK parameters of interest. | Posted | Median | Full Range | Days | Cycle 0: from Cycle 0 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days]; Cycle 1: from Cycle 1 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days] |
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| Secondary | Area Under the Concentration-time Profile From Time Zero to the Time Tau (AUCtau) of Elranatamab | Area under the concentration-time profile from time zero to the time tau where the dosing interval (tau = 1 week). AUCtau was determined using the linear/log trapezoidal method. | Pharmacokinetic parameter analysis population was defined as all enrolled participants treated who did not have protocol deviations influencing PK assessment, and had sufficient information to estimate at least 1 of the PK parameters of interest. Here, 'Number Analyzed' signifies participants evaluable at specified rows. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram*day per milliliter | Cycle 0: from Cycle 0 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days]; Cycle 1: from Cycle 1 Day 1 (pre dose to the next dose of study intervention) [maximum of 9 days] |
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| Secondary | Pre-dose Trough Serum Concentrations After Multiple Doses of Elranatamab | Pharmacokinetic concentration population was defined as all enrolled participants who were treated and had at least 1 analyte concentration. Here, 'Number Analyzed' signifies participants evaluable at specific timepoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | At pre-dose on Day 1 of Cycle 0, 3, 4, 5, 6, 7, 8, 12, 16; at pre-dose on Days 1, 8, 15 of Cycle 1 and 2 |
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| Secondary | Number of Participants With Anti-drug Antibodies (ADA) of Elranatamab | 'A participant was considered ADA positive if baseline titer was missing or negative and participant had >=1 post-treatment positive titer, or positive titer at baseline and had a >=4-fold increase in titer from baseline in >=1 post-treatment sample. | Immunogenicity analysis set included all enrolled participants who received at least one dose of study treatment and had at least one sample tested for ADA. | Posted | Count of Participants | Participants | From the date of first dose up to maximum of 65.1 weeks of treatment |
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| Secondary | Titers of ADA | Titers of ADA at specified timepoints were reported in this outcome measure. | Immunogenicity analysis set included all enrolled participants who received at least one dose of study treatment and had at least one sample tested for ADA. Here, 'Number of Participants Analyzed' signifies ADA positive participants with at least one evaluable sample. 'Number Analyzed' signifies participants with non-missing ADA titers at each time point. | Posted | Mean | Standard Deviation | Titers | Cycle1 Day1, Cycle1 Day15, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1, Cycle6 Day1, Cycle8 Day1, Cycle12 Day1, Cycle16 Day1, End of treatment (maximum of 65.1 weeks of treatment) |
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| Secondary | Number of Participants With Neutralizing Antibodies (NAb) | A participant was considered NAb positive if baseline titer was missing or negative and participant had >=1 post-treatment positive titer, or positive titer at baseline and had a >=4-fold increase in titer from baseline in >=1 post-treatment sample. | Immunogenicity analysis set included all enrolled participants who received at least one dose of study treatment and had at least one sample tested for ADA. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From the date of first dose up to maximum of 65.1 weeks of treatment |
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| Secondary | Objective Response Rate (ORR): Percentage of Participants With Objective Response | ORR:% of participants with best overall response; confirmed stringent complete response(sCR),CR, very good partial response(VGPR) or PR per International Myeloma Working Group criteria.sCR: CR& normal serum free light chain(sFLC)ratio &absence of clonal cells in BMB/BMA by immunohistochemistry, immunofluorescence or flow cytometry.CR: negative immunofixation on serum &urine, disappearance of soft tissue plasmacytoma &<5% plasma cells in BMA, if disease measured by sFLC only,preceding criteria plus normal sFLC ratio.VGPR:Serum & urine M-protein detectable by immunofixation but not on electrophoresis; or >=90% reduction in serum&urine M-protein level <100mg/24h.PR:>=50% reduction in serum M-protein & reduction in 24h urinary M-protein by >=90% or <200 mg/24h. If serum & urine M-protein unmeasurable,VGPR & PR: >=90% &>=50% decrease in difference respectively between involved & uninvolved sFLC levels & if present at baseline,>=90% & >=50% reduction in soft tissue plasmacytomas' size. | SAS included all enrolled participants who received at least 1 dose of study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (maximum of 65.1 weeks of treatment) |
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| Secondary | Time to Response (TTR) | TTR was defined for participants with confirmed objective response (sCR,CR,VGPR and PR) as the time from first date of study intervention to the date of first documentation of objective response. sCR: CR and normal sFLC ratio with absence of clonal cells in BMB/BMA by immunohistochemistry, immunofluorescence or flow cytometry.CR: negative immunofixation on serum and urine,disappearance of soft tissue plasmacytoma, <5% plasma cells in BMA, if disease measured by sFLC only,preceding criteria plus normal sFLC ratio.VGPR:Serum and urine M-protein detectable by immunofixation but not on electrophoresis; or >=90% reduction in serum and urine M-protein level <100mg/24h.PR:>=50% reduction in serum M-protein and reduction in 24h urinary M-protein by >=90% or <200 mg/24h.If serum and urine M-protein unmeasurable,VGPR & PR: >=90%,>=50% decrease in difference respectively between involved and uninvolved sFLC levels,if present at baseline,>=90%, >=50% reduction in soft tissue plasmacytomas' size. | SAS included all enrolled participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Median | Full Range | Months | From date of first dose to the first documentation of objective response that is subsequently confirmed (maximum of 65.1 weeks of treatment) |
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| Secondary | Duration of Response (DOR) | DOR: time from first documentation of objective response subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease. | SAS included all enrolled participants who received at least 1 dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | Months | From first documentation of objective response subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurs first, or censoring date (maximum of 65.1 weeks of treatment) |
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| Secondary | Progression Free Survival (PFS) | Progression free survival (PFS) was the time from the first date of the study intervention to the date of the first documentation of confirmed progression, or death due to any cause. | SAS included all enrolled participants who received at least 1 dose of study intervention. | Posted | Median | 95% Confidence Interval | Months | From date of first dose until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurs first, or censoring date (maximum of 65.1 weeks of treatment) |
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| Secondary | Overall Survival (OS) | Overall survival (OS) was the time from the first date of the study intervention to the date of death due to any cause. Participants not known to have died are censored on the date of last known alive. | SAS included all enrolled participants who received at least 1 dose of study intervention. | Posted | Median | 95% Confidence Interval | Months | From the date of first dose until death due to any cause or censoring date (maximum of 65.1 weeks of treatment) |
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| Secondary | Minimal Residual Disease (MRD) Negativity Rate | MRD negativity rate was defined as percentage of participants with CR or sCR with negative MRD per IMWG sequencing criteria by bone marrow aspirate (BMA). sCR: CR and normal sFLC ratio with absence of clonal cells in BMB/BMA by immunohistochemistry, immunofluorescence or flow cytometry.CR: negative immunofixation on serum and urine, disappearance of soft tissue plasmacytoma and <5% plasma cells in BMA, if disease measured by sFLC only, preceding criteria plus normal sFLC ratio. MRD was reported at threshold frequency of 10^5 and 10^6. | SAS included all enrolled participants who received at least 1 dose of study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (maximum of 65.1 weeks of treatment) |
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| 2 |
| 4 |
| 3 |
| 4 |
| 4 |
| 4 |
| Malaise | General disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Injection site reaction | General disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Cytokine release syndrome | Immune system disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Hypogammaglobulinaemia | Immune system disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Cytomegalovirus infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Cytomegalovirus infection reactivation | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Tooth loss | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Weight decreased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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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.
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
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| Treatment Emergent Treatment Related SAEs |
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| Title | Measurements |
|---|---|
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| ICANS events |
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| Title | Measurements |
|---|---|
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| Platelet count decreased |
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| White blood cell decreased |
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| Title | Measurements |
|---|---|
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| Blood bilirubin increased |
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| Creatinine increased |
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| Hypercalcemia |
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| Hyperkalemia |
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| Hypermagnesemia |
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| Hypernatremia |
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| Hypoalbuminemia |
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| Hypocalcemia |
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| Hypoglycemia |
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| Hypokalemia |
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| Hypomagnesemia |
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| Hyponatremia |
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| Cycle 1 Day8: Predose |
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| Cycle 1 Day15: Predose |
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| Cycle 2 Day1: Predose |
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| Cycle 2 Day8: Predose |
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| Cycle 2 Day15: Predose |
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| Cycle 3 Day1: Predose |
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| Cycle 4 Day1: Predose |
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| Cycle 5 Day1: Predose |
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| Cycle 6 Day1: Predose |
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| Cycle 7 Day1: Predose |
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| Cycle 8 Day1: Predose |
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| Cycle 12 Day1: Predose |
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| Cycle 16 Day1: Predose |
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| Cycle3 Day1 |
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| Cycle4 Day1 |
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| Cycle6 Day1 |
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| Cycle8 Day1 |
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| Cycle12 Day1 |
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| Cycle16 Day1 |
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| End of treatment |
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