Trial Outcomes & Findings for Effects of Maplirpacept (PF-07901801),Tafasitamab, and Lenalidomide in People With Relapsed or Refractory Diffuse Large B-cell Lymphoma (NCT NCT05626322)
NCT ID: NCT05626322
Last Updated: 2025-09-05
Results Overview
DLTs included: Hematological: Grade (G) 4 thrombocytopenia (\<25,000/microliter \[mcL\]) lasting \>=72 hours or a platelet count \<=10,000/mcL at any time, unexplained by underlying disease; \>=G3 thrombocytopenia associated with \>=G2 bleeding, unexplained by underlying disease. G4 anemia; unexplained by underlying disease; G4 neutropenia lasting \>=7 days, unexplained by underlying disease; G3 febrile (\>38.3-degree Celsius \[C\]) neutropenia lasting \>=7 days, unexplained by underlying disease; G4 febrile neutropenia unexplained by underlying disease. Non-hematological: any treatment-related \>=G3 non-hematologic toxicity; Other \>=G2 PF-07901801-related non-hematologic toxicities that, in the opinion of the investigator, required a dose reduction or discontinuation of PF-07901801 were considered a DLT.
TERMINATED
PHASE1/PHASE2
6 participants
Cycle 1 (28 Days)
2025-09-05
Participant Flow
A total of 9 participants were screened of which 3 participants failed screening, and 6 participants were enrolled and received study treatment.
The study was planned to be conducted in 2 parts: phase 1b dose escalation and phase 2 dose expansion. Phase 2 of the study was not initiated per business decision made by Sponsor; hence, data for Phase 2 is not reported in any part of the record.
Participant milestones
| Measure |
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly (QW) during Cycle 1 to 3 followed by twice weekly (Q2W) dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 milligrams (mg) by mouth (PO) on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
1
|
Reasons for withdrawal
| Measure |
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once weekly (QW) during Cycle 1 to 3 followed by twice weekly (Q2W) dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 milligrams (mg) by mouth (PO) on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
|---|---|---|---|
|
Overall Study
Death
|
2
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Progressive Disease
|
0
|
1
|
1
|
|
Overall Study
Study terminated by sponsor
|
0
|
1
|
0
|
Baseline Characteristics
Effects of Maplirpacept (PF-07901801),Tafasitamab, and Lenalidomide in People With Relapsed or Refractory Diffuse Large B-cell Lymphoma
Baseline characteristics by cohort
| Measure |
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=3 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
n=1 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Age · 18-44 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Customized
Age · 45-64 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Age, Customized
Age · >=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Gender · Not disclosed
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Not disclosed
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not disclosed
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (28 Days)Population: DLT evaluable set included all enrolled participants who received at least 1 dose of the study treatment in the Phase 1b of the study and either experienced DLTs or completed the DLT observation period without DLT.
DLTs included: Hematological: Grade (G) 4 thrombocytopenia (\<25,000/microliter \[mcL\]) lasting \>=72 hours or a platelet count \<=10,000/mcL at any time, unexplained by underlying disease; \>=G3 thrombocytopenia associated with \>=G2 bleeding, unexplained by underlying disease. G4 anemia; unexplained by underlying disease; G4 neutropenia lasting \>=7 days, unexplained by underlying disease; G3 febrile (\>38.3-degree Celsius \[C\]) neutropenia lasting \>=7 days, unexplained by underlying disease; G4 febrile neutropenia unexplained by underlying disease. Non-hematological: any treatment-related \>=G3 non-hematologic toxicity; Other \>=G2 PF-07901801-related non-hematologic toxicities that, in the opinion of the investigator, required a dose reduction or discontinuation of PF-07901801 were considered a DLT.
Outcome measures
| Measure |
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
n=1 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
|---|---|---|---|
|
Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)Population: Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs are those events with onset dates occurred during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period.
Outcome measures
| Measure |
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=3 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
n=1 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
|---|---|---|---|
|
Phase 1b: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
3 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)Population: Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/ incapacity, was a congenital anomaly/birth defect or other important medical event. TEAEs are those events with onset dates occurred during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period.
Outcome measures
| Measure |
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=3 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
n=1 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
|---|---|---|---|
|
Phase 1b: Number of Participants With Serious Treatment Emergent Adverse Events
|
3 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)Population: Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Related AEs were those related to any study drug (i.e., at least one of the study drugs) reported by the investigator.
Outcome measures
| Measure |
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=3 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
n=1 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
|---|---|---|---|
|
Phase 1b: Number of Participants With Treatment-Related AEs
|
3 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From baseline (latest non-missing value from pre-treatment period) up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)Population: Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
The following hematological parameters were assessed: anemia, hemoglobin increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, and white blood cell (WBC) decreased. Lab abnormalities were graded according to National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) version (v) 5.0 where Grade 0= no AE, Grade 1= mild AE, Grade 2 =moderate AE, Grade 3= severe AE, and Grade 4= life-threatening consequences; urgent intervention indicated. Only those parameters with at least 1 non-zero data values showing any shift in grades from Baseline to any time post-baseline in any reporting group were reported in this outcome measure. Participants whose grade category was unchanged (e.g. Grade 0 to Grade 0) were not reported.
Outcome measures
| Measure |
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=3 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
n=1 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
|---|---|---|---|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Anemia: Grade 1 to Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Lymphocyte count decreased: Grade 0 to Grade 2
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Lymphocyte count decreased: Grade 0 to Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Lymphocyte count decreased: Grade 1 to Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Lymphocyte count decreased: Grade 1 to Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Lymphocyte count increased: Grade 0 Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Neutrophil count decreased: Grade 0 to Grade 2
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Neutrophil count decreased: Grade 0 to Grade 4
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Platelet count decreased: Grade 0 to Grade 1
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
WBC decreased: Grade 0 to Grade 1
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Anemia: Grade 2 to Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Leukocytosis: Grade 0 Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Neutrophil count decreased: Grade 0 to Grade 3
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Platelet count decreased: Grade 0 to Grade 4
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
Platelet count decreased: Grade 1 to Grade 4
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
WBC decreased: Grade 0 to Grade 2
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
WBC decreased: Grade 0 to Grade 4
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline
WBC decreased: Grade 1 to Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline (latest non-missing value from pre-treatment period) up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)Population: Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
The following clinical chemistry parameters were assessed: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia and hyponatremia. Lab abnormalities were graded according to NCI CTCAE v5.0 where Grade 0= no AE, Grade 1=mild AE, Grade 2 = moderate AE, Grade 3 =severe AE, and Grade 4 =life-threatening consequences; urgent intervention indicated. Only those parameters with at least 1 non-zero data values showing any shift in grades from Baseline to any time post-baseline in any reporting group were reported in this outcome measure. Participants whose grade category was unchanged (e.g. Grade 0 to Grade 0) were not reported.
Outcome measures
| Measure |
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=3 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
n=1 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
|---|---|---|---|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Alanine aminotransferase increased: Grade 0 to Grade 1
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Blood bilirubin increased: Grade 0 to Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Creatinine increased: Grade 0 to Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Hypermagnesemia: Grade 0 to Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Hypernatremia: Grade 0 to Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Hypoalbuminemia: Grade 1 to Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Hypocalcemia: Grade 0 to Grade 1
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Hypokalemia: Grade 0 to Grade 2
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Hypomagnesemia: Grade 0 to Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Hyponatremia: : Grade 0 to Grade 1
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Alanine aminotransferase increased: Grade 1 to Grade 0
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Alkaline phosphatase increased: Grade 0 to Grade 1
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Alkaline phosphatase increased: Grade 1 to Grade 0
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Aspartate aminotransferase increased: Grade 0 to Grade 1
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Blood bilirubin increased: Grade 0 to Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Creatinine increased: Grade 0 to Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Creatinine increased: Grade 1 to Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Hypercalcemia: Grade 0 to Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Hyperkalemia: Grade 0 to Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Hypoalbuminemia: Grade 1 to Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline
Hypomagnesemia: Grade 0 to Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From date of first dose until first documentation of disease progression (PD), death or start of new anticancer therapy, whichever occurred first (maximum up to 14.2 months)Population: Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
OR:best overall response (BOR) of complete response (CR) or partial response (PR) per Lugano Response Classification Criteria 2014 as determined by investigator. CR:positron emission tomography-computed tomography (PET-CT) score 1 (complete metabolic response), 2 (likely benign), or 3 (uncertain significance) with or without a residual mass on Deauville five-point scale (\[5PS\] standardized scoring system used to evaluate the extent of disease activity in patients with lymphoma through PET scans, ranging from 1 to 5, higher scores indicates more disease activity) or on computed tomography (CT),target nodes/nodal masses regressed to \<=1.5 centimeter (cm) in longest diameter (LDi). PR:PET-CT score 4 (possible residual disease) or 5 (progressive disease) with reduced uptake compared with baseline and residual mass(es) of any size or On CT \>=50% decrease in sum of the product of the diameters (SPD) of up to 6 target measurable nodes and extra nodal sites. 95% CI was based on Wilson method.
Outcome measures
| Measure |
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=3 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
n=1 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
|---|---|---|---|
|
Phase 1b: Percentage of Participants With Objective Response (OR) as Per Lugano Response Classification Criteria 2014 as Assessed by the Investigator
|
66.7 Percentage of participants
Interval 12.5 to 98.2
|
100.0 Percentage of participants
Interval 19.8 to 100.0
|
0 Percentage of participants
Interval 0.0 to 94.5
|
SECONDARY outcome
Timeframe: From first documentation of OR until PD or death due to any cause whichever occurred first or date of censoring (maximum up to 14.2 months)Population: Safety analysis set included all enrolled participants who received at least 1 dose of study treatment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Only participants with objective response were included in the analysis.
DoR: time from first documentation of OR until PD, or death due to any cause, whichever occurred first. DoR was censored on date of last adequate disease assessment for participants without an event. OR=BOR of CR or PR,CR=PET-CT score 1,2,or 3 with/without a residual mass on Deauville five-point scale(1 to 5,higher scores=more disease activity)or on CT,target nodes/nodal masses regressed to \<=1.5cm in LDi. PR:PET-CT score 4 or 5 with reduced uptake compared with baseline and residual mass of any size or On CT \>=50% decrease in SPD of up to 6 target measurable nodes and extra nodal sites. PD:PET-CT score 4 or 5 with increase in intensity of uptake from baseline and/or new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma at interim or end-of-treatment assessment or on CT,an individual abnormal node/lesion with: LDi\>1.5cm and increase by \>=50% from product of perpendicular diameters nadir and increase in LDi or SDi from nadir 0.5cm for lesions \<=2cm and 1.0cm for lesions \>2cm.
Outcome measures
| Measure |
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
|---|---|---|---|
|
Phase 1b: Duration of Response (DoR) as Per Lugano Response Classification Criteria 2014 as Assessed by the Investigator
|
11.9 Months
Interval 9.6 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
NA Months
Interval 3.3 to
Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
—
|
SECONDARY outcome
Timeframe: From date of first dose until first documentation of CR (maximum up to 14.2 months)Population: Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
CR as per Lugano Response Classification Criteria 2014 as assessed by the investigator was defined as: PET-CT score 1 (complete metabolic response), 2 (likely benign), or 3 (uncertain significance) with or without a residual mass on 5PS (standardized scoring system used to evaluate the extent of disease activity in patients with lymphoma through PET scans, ranging from 1 to 5, higher scores indicates more disease activity) or on CT, target nodes/nodal masses regressed to \<=1.5 cm in LDi.
Outcome measures
| Measure |
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=3 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
n=1 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
|---|---|---|---|
|
Phase 1b: Percentage of Participants With CR as Per Lugano Response Classification Criteria 2014 as Assessed by the Investigator
|
66.7 Percentage of participants
Interval 12.5 to 98.2
|
100.0 Percentage of participants
Interval 19.8 to 100.0
|
0.0 Percentage of participants
Upper and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From time of first documentation of CR until PD, or death due to any cause, whichever occurred first or date of censoring (maximum up to 14.2 months)Population: Safety analysis set included all enrolled participants who received at least 1 dose of study treatment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Only participants with complete response were included in the analysis.
DoCR:time from first documentation of CR until PD,or death, whichever occurred first. CR:PET-CT 1(complete metabolic response),2(likely benign),3(uncertain significance)with or without residual mass on 5PS(scale from 1 to 5,higher scores=more disease activity)/CT,target nodes/nodal masses regressed \<=1.5cm in LDi.PD:PET-CT 4(possible residual disease)or 5(PD)with increase intensity of uptake and new FDG-avid foci consistent with lymphoma at interim/EOT assessment/CT,individual abnormal node/lesion with:LDi \>1.5cm and increase \>=50% from PPD nadir, increase in LDi or SDi from nadir 0.5cm for lesions \<=2cm and 1.0cm for lesions \>2cm. DoCR censored on date of last adequate assessment for participants without an event on date of last adequate disease assessment before new anti-cancer therapy if new anti-cancer therapy started prior to event,date of last adequate disease assessment before 2 or more missing disease assessments for participants with event after 2 or more missing assessments.
Outcome measures
| Measure |
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
|---|---|---|---|
|
Phase 1b: Duration of Complete Response (DoCR) as Per Lugano Response Classification Criteria 2014 as Assessed by the Investigator
|
11.9 Months
Interval 9.6 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
NA Months
Interval 3.3 to
Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
—
|
SECONDARY outcome
Timeframe: From date of first dose until PD or death due to any cause, whichever occurred first or censoring date (maximum up to 14.2 months)Population: Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
PFS: time from date of first dose until PD per Lugano Response Classification Criteria 2014 or death due to any cause,whichever occurred first.Participants without any event,censored on date of last adequate disease assessment;participants with new anticancer therapy prior to an event,censored on date of last disease assessment before new anticancer therapy;participants with an event after a gap of 2 or more missing disease assessments,censored on date of last disease assessment before gap;participants without an adequate post-baseline disease assessment were censored on date of first dose of study intervention unless death occurred on or before time of second planned disease assessment in which case death was considered an event.PD:PET-CT score 4 or 5 with increase in intensity of uptake from baseline and/or new FDG or LDi\>1.5cm and increase by \>=50% from product of perpendicular diameters nadir and increase in LDi or SDi from nadir 0.5cm for lesions \<=2cm and 1.0cm for lesions \>2cm.
Outcome measures
| Measure |
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=3 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
n=1 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
|---|---|---|---|
|
Phase 1b: Progression Free Survival (PFS) as Per Lugano Response Classification Criteria 2014 as Assessed by the Investigator
|
13.7 Months
Interval 11.4 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
NA Months
Interval 5.6 to
Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
1.2 Months
Upper and lower limit of 95% CI could not be estimated due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Cycle 1 and 2 Day 1: Predose, 1 Hour (H) and 5H post dose; Cycle 1 Day 8: pre-dose, Day 1 of Cycles 3, 4, 5, 7, 10 and 13: PredosePopulation: The Pharmacokinetic (PK) analysis set included all participants in the safety analysis set who had at least 1 post-dose concentration measurement. Here, "Number Analyzed" signifies number of participants evaluable at specified timepoints. The participant in PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide withdrew consent hence, the "Overall Number of Participants Analyzed" is reported as 0.
All concentrations assayed below the level of quantification (BLQ) were set to 0 and their data is not reported in this outcome measure.
Outcome measures
| Measure |
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=3 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
|---|---|---|---|
|
Phase 1b: Plasma Concentration of PF-07901801
Cycle 1 Day 1: Predose
|
—
|
0.1 Micrograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimated as only 1 participant was analyzed.
|
—
|
|
Phase 1b: Plasma Concentration of PF-07901801
Cycle 1 Day 1: 1 hour
|
64.3 Micrograms per milliliter
Geometric Coefficient of Variation 45
|
213.4 Micrograms per milliliter
Geometric Coefficient of Variation 31
|
—
|
|
Phase 1b: Plasma Concentration of PF-07901801
Cycle 1 Day 1: 5 hours
|
50.7 Micrograms per milliliter
Geometric Coefficient of Variation 47
|
194.2 Micrograms per milliliter
Geometric Coefficient of Variation 42
|
—
|
|
Phase 1b: Plasma Concentration of PF-07901801
Cycle 1 Day 8: Predose
|
4.0 Micrograms per milliliter
Geometric Coefficient of Variation 159
|
21.1 Micrograms per milliliter
Geometric Coefficient of Variation 85
|
—
|
|
Phase 1b: Plasma Concentration of PF-07901801
Cycle 2 Day 1: Predose
|
7.9 Micrograms per milliliter
Geometric Coefficient of Variation 201
|
88.3 Micrograms per milliliter
Geometric Coefficient of Variation 35
|
—
|
|
Phase 1b: Plasma Concentration of PF-07901801
Cycle 2 Day 1: 1 hour
|
75.3 Micrograms per milliliter
Geometric Coefficient of Variation 63
|
308.1 Micrograms per milliliter
Geometric Coefficient of Variation 42
|
—
|
|
Phase 1b: Plasma Concentration of PF-07901801
Cycle 2 Day 1: 5 hours
|
67.6 Micrograms per milliliter
Geometric Coefficient of Variation 71
|
276.4 Micrograms per milliliter
Geometric Coefficient of Variation 31
|
—
|
|
Phase 1b: Plasma Concentration of PF-07901801
Cycle 3 Day 1: Predose
|
10.9 Micrograms per milliliter
Geometric Coefficient of Variation 168
|
130.4 Micrograms per milliliter
Geometric Coefficient of Variation 10
|
—
|
|
Phase 1b: Plasma Concentration of PF-07901801
Cycle 4 Day 1: Predose
|
15.0 Micrograms per milliliter
Geometric Coefficient of Variation 190
|
75.1 Micrograms per milliliter
Geometric Coefficient of Variation 110
|
—
|
|
Phase 1b: Plasma Concentration of PF-07901801
Cycle 5 Day 1: Predose
|
2.0 Micrograms per milliliter
Geometric Coefficient of Variation 57
|
35.2 Micrograms per milliliter
Geometric Coefficient of Variation 187
|
—
|
|
Phase 1b: Plasma Concentration of PF-07901801
Cycle 7 Day 1: Predose
|
2.3 Micrograms per milliliter
Geometric Coefficient of Variation 20
|
21.0 Micrograms per milliliter
Geometric Coefficient of Variation 50
|
—
|
|
Phase 1b: Plasma Concentration of PF-07901801
Cycle 10 Day 1: Predose
|
2.0 Micrograms per milliliter
Geometric Coefficient of Variation 15
|
28.6 Micrograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimated as only 1 participant was analyzed.
|
—
|
|
Phase 1b: Plasma Concentration of PF-07901801
Cycle 13 Day 1: Predose
|
1.6 Micrograms per milliliter
Geometric Coefficient of Variation 83
|
26.9 Micrograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation was not estimated as only 1 participant was analyzed.
|
—
|
SECONDARY outcome
Timeframe: From first dose of the study treatment (Day 1) up to end of study treatment (maximum up to 14.2 months)Population: Immunogenicity analysis set included all participants in the safety analysis set who had at least 1 sample tested for ADA.
Number of participants with ADA and NAb against PF-07901801 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).
Outcome measures
| Measure |
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=3 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
n=1 Participants
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
|---|---|---|---|
|
Phase 1b: Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Against PF-07901801
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
Serious adverse events
| Measure |
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=3 participants at risk
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 participants at risk
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
n=1 participants at risk
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
|---|---|---|---|
|
Infections and infestations
Appendicitis
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Sepsis
|
66.7%
2/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
Other adverse events
| Measure |
PF-07901801 4 mg/kg + Tafasitamab + Lenalidomide
n=3 participants at risk
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 4 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 10 mg/kg + Tafasitamab + Lenalidomide
n=2 participants at risk
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 10 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
PF-07901801 18 mg/kg + Tafasitamab + Lenalidomide
n=1 participants at risk
Participants with relapsed/refractory diffuse large B cell lymphoma received PF-07901801 18 mg/kg as an IV infusion QW during Cycle 1 to 3 followed by Q2W dosing from Cycle 4 onwards along with tafasitamab 12 mg/kg as an IV infusion on Days 1, 4, 8, 15 and 22 of Cycle 1, QW during Cycle 2 and 3 and Q2W from Cycle 4 onwards. Participants were administered lenalidomide 25 mg PO on Days 1 through 21 of each cycle for up to 12 cycles. Each Cycle = 28 Days. Participants received treatment until disease progression, start of new anti-cancer therapy or death, whichever occurred first.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Vision blurred
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Visual impairment
|
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
100.0%
2/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gingival ulceration
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
General disorders
Fatigue
|
66.7%
2/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
General disorders
Influenza like illness
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
General disorders
Pain
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
66.7%
2/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Herpes zoster
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Oral infection
|
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Soft tissue infection
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
66.7%
2/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
100.0%
2/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood creatinine increased
|
66.7%
2/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Investigations
International normalised ratio increased
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Investigations
Neutrophil count decreased
|
100.0%
3/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Investigations
White blood cell count decreased
|
66.7%
2/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Investigations
White blood cell count increased
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
33.3%
1/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)
Same event may appear as non-SAE and SAE, however, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor (or its agents) has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication 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.
- Publication restrictions are in place
Restriction type: OTHER