Trial Outcomes & Findings for A Study of Modakafusp Alfa in Adult Participants With Multiple Myeloma (NCT NCT05556616)
NCT ID: NCT05556616
Last Updated: 2025-12-19
Results Overview
DLT was defined by national cancer institute common terminology criteria for adverse events (NCI CTCAE) version 5.0: Grade 5 AE; Hematologic toxicity: Nonfebrile Grade 4 neutropenia lasting more than 7 consecutive days/Grade greater than or equal to (\>=) 3 febrile neutropenia; Grade 4 thrombocytopenia lasting more than 14 consecutive days, Grade 3 thrombocytopenia with clinically significant bleeding; any other Grade 4 with exceptions; Nonhematologic Grade 3 or higher toxicities unrelated to the underlying disease with exceptions.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Cycle 1 (Cycle length is 28 days)
Results posted on
2025-12-19
Participant Flow
Participants took part in the study at various investigative sites globally from 12 January 2023 to 04 June 2024.
Participants with a diagnosis of multiple myeloma (MM) were enrolled in this study. Participants with newly diagnosed MM (NDMM) received modakafusp alfa in combination with lenalidomide and participants with relapsed/refractory MM (RRMM) received modakafusp alfa in combination with pomalidomide or carfilzomib. Due to early termination of the study no participants were enrolled in Group 2 Arm 4: modakafusp alfa + bortezomib and Group 3 arms.
Participant milestones
| Measure |
Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg
Participants received 80 milligrams (mg) modakafusp alfa, infusion intravenously (IV), once on Day 1, once every 4 weeks (Q4W), in combination with 10 mg lenalidomide capsules orally once daily continuously on Days 1 to 28, in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or to a maximum of 2 years for measurable/minimal residual disease-negative (MRD \[-\]) participants, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 2 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 4 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 20/70 milligrams per meter square (mg/m\^2) carfilzomib IV, on Day 1, 8 and 15 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
Group 2 (RRMM Doublets) Arm 4: Modakafusp Alfa + Bortezomib
Participants were planned to receive modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with bortezomib injection subcutaneously on Days 8, 15, and 22 for the first 8 cycles and subsequently on Days 8 and 22 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.
|
Group 3 (RRMM Triplets): Modakafusp Alfa + Pomalidomide + Bortezomib
Participants were planned to receive modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle along with bortezomib injection subcutaneously on Days 8, 15 and 22 for the first 8 cycles and subsequently on Days 8 and 22 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.
|
Group 3 (RRMM Triplets): Modakafusp Alfa + Daratumumab + Pomalidomide
Participants were planned to receive modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with daratumumab injection subcutaneously on Days 1, 8, 15 and 22 of Cycles 1 and 2, further followed by on Days 1 and 15 of Cycles 3 to 6, thereafter on Day 1 on a 28-day (4-week) treatment cycle along with pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
4
|
3
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
2
|
1
|
2
|
2
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
2
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg
Participants received 80 milligrams (mg) modakafusp alfa, infusion intravenously (IV), once on Day 1, once every 4 weeks (Q4W), in combination with 10 mg lenalidomide capsules orally once daily continuously on Days 1 to 28, in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or to a maximum of 2 years for measurable/minimal residual disease-negative (MRD \[-\]) participants, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 2 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 4 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 20/70 milligrams per meter square (mg/m\^2) carfilzomib IV, on Day 1, 8 and 15 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
Group 2 (RRMM Doublets) Arm 4: Modakafusp Alfa + Bortezomib
Participants were planned to receive modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with bortezomib injection subcutaneously on Days 8, 15, and 22 for the first 8 cycles and subsequently on Days 8 and 22 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.
|
Group 3 (RRMM Triplets): Modakafusp Alfa + Pomalidomide + Bortezomib
Participants were planned to receive modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle along with bortezomib injection subcutaneously on Days 8, 15 and 22 for the first 8 cycles and subsequently on Days 8 and 22 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.
|
Group 3 (RRMM Triplets): Modakafusp Alfa + Daratumumab + Pomalidomide
Participants were planned to receive modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with daratumumab injection subcutaneously on Days 1, 8, 15 and 22 of Cycles 1 and 2, further followed by on Days 1 and 15 of Cycles 3 to 6, thereafter on Day 1 on a 28-day (4-week) treatment cycle along with pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
2
|
1
|
0
|
0
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Modakafusp Alfa in Adult Participants With Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg
n=3 Participants
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W, in combination with 10 mg lenalidomide capsules orally once daily continuously on Days 1 to 28, in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or to a maximum of 2 years for MRD \[-\] negative participants, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg
n=4 Participants
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 2 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg
n=4 Participants
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 4 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2
n=3 Participants
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 20/70 mg/m\^2 carfilzomib IV, on Day 1, 8 and 15 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 18.50 • n=8 Participants
|
64.3 years
STANDARD_DEVIATION 11.00 • n=6 Participants
|
71.3 years
STANDARD_DEVIATION 2.63 • n=6 Participants
|
57.3 years
STANDARD_DEVIATION 12.06 • n=9 Participants
|
64.4 years
STANDARD_DEVIATION 11.47 • n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=8 Participants
|
4 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
10 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=8 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
11 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=8 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=8 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=8 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
7 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (Cycle length is 28 days)Population: The DLT-evaluable Analysis Set included participants who experienced a DLT in Cycle 1 in the treatment phase of the study or completed Cycle 1 procedures and received a full Cycle 1 dose of modakafusp alfa and at least 75% of the planned dose of the combination partner. Due to early termination of the study no participants were enrolled in Group 2 Arm 4: modakafusp alfa + bortezomib and Group 3 arms, thus they are not presented here.
DLT was defined by national cancer institute common terminology criteria for adverse events (NCI CTCAE) version 5.0: Grade 5 AE; Hematologic toxicity: Nonfebrile Grade 4 neutropenia lasting more than 7 consecutive days/Grade greater than or equal to (\>=) 3 febrile neutropenia; Grade 4 thrombocytopenia lasting more than 14 consecutive days, Grade 3 thrombocytopenia with clinically significant bleeding; any other Grade 4 with exceptions; Nonhematologic Grade 3 or higher toxicities unrelated to the underlying disease with exceptions.
Outcome measures
| Measure |
Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg
n=2 Participants
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W, in combination with 10 mg lenalidomide capsules orally once daily continuously on Days 1 to 28, in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or to a maximum of 2 years for MRD \[-\] negative participants, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg
n=3 Participants
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 2 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg
n=4 Participants
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 4 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2
n=2 Participants
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 20/70 milligrams per meter square (mg/m\^2) carfilzomib IV, on Day 1, 8 and 15 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
|---|---|---|---|---|
|
Number of Participants With Dose-limiting Toxicities (DLTs)
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 16.7 monthsPopulation: The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug. Due to early termination of the study no participants were enrolled in Group 2 Arm 4: modakafusp alfa + bortezomib and Group 3 arms, thus they are not presented here.
An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.
Outcome measures
| Measure |
Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg
n=3 Participants
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W, in combination with 10 mg lenalidomide capsules orally once daily continuously on Days 1 to 28, in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or to a maximum of 2 years for MRD \[-\] negative participants, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg
n=4 Participants
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 2 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg
n=4 Participants
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 4 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2
n=3 Participants
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 20/70 milligrams per meter square (mg/m\^2) carfilzomib IV, on Day 1, 8 and 15 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
|---|---|---|---|---|
|
Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs)
|
3 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 16.7 monthsPFS was defined as the time from the date on which the first dose of study drug is administered to the date of first documentation of confirmed progression of disease (PD) or death due to any cause, whichever occurs first. PD was determined by International Myeloma Working Group (IMWG) criteria. PD: increase of ≥25 percent (%) from lowest response value in any one or more of the following: serum M-component increase ≥0.5 gram per deciliter (g/dL) or urine M-component increase ≥200 milligram (mg)/24-hour; difference between involved and uninvolved free light chains (FLC) levels increase must be greater than (\>) 10 milligram per deciliter (mg/dL); bone marrow plasma cell ≥10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 16.7 monthsPopulation: Response-Evaluable Analysis Set was a subset of SAS including participants with measurable disease at baseline \& at least 1 post-baseline efficacy evaluation.
ORR: percentage of participants achieving confirmed partial response rate(PR)or better(stringent complete response\[sCR\]+complete response\[CR\]+very good partial response\[VGPR\]+PR)during study as defined by IMWG uniform response criteria and as determined by investigator.PR:\>=50%reduction of serum M-protein and\>=90% reduction in urine M-protein or less than(\<)200mg/24 hour, or\>=50%decrease in uninvolved FLC or \>=50% reduction in plasma cells. At baseline,a \>=50% decrease in size of soft tissue plasmacytomas was required. Percentages were rounded off to nearest single decimal place. Due to early termination of study no participants were enrolled in Group 2 Arm 4: modakafusp alfa+bortezomib and Group 3 arms, thus they are not presented here. Also, no participants in Group 1 fulfilled criteria for Response-Evaluable Analysis Set, hence are not presented here. Given limited number of participants and low confidence interval as a consequence, those response rate provides limited information.
Outcome measures
| Measure |
Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg
n=4 Participants
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W, in combination with 10 mg lenalidomide capsules orally once daily continuously on Days 1 to 28, in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or to a maximum of 2 years for MRD \[-\] negative participants, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg
n=4 Participants
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 2 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg
n=3 Participants
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 4 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 20/70 milligrams per meter square (mg/m\^2) carfilzomib IV, on Day 1, 8 and 15 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
0 percentage of participants
Interval 0.0 to 60.24
|
50 percentage of participants
Interval 6.76 to 93.24
|
33.3 percentage of participants
Interval 0.84 to 90.57
|
—
|
SECONDARY outcome
Timeframe: Up to 16.7 monthsDOR was defined as the time from the date of first documentation of confirmed PR or better (sCR+ CR+ VGPR+ PR) to the date of first documentation of PD or death due to any cause. PR: \>=50% reduction of serum M-protein and \>=90% reduction in urine M-protein or \<200 mg/24 hour, or \>=50% decrease in uninvolved FLC or \>=50% reduction in plasma cells. At baseline, a \>=50% decrease in size of soft tissue plasmacytomas is required. PD: increase of \>=25% from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \>10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 16.7 monthsOS was defined as the time from the first dose of administration to the date of death, due to any cause. Participants without documentation of death at the time of analysis were censored at the date last known to be alive.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 16.7 monthsTTP was defined as the time from the date of the first dose until the earliest date of confirmed PD per IMWG, or death due to PD. PD: increase of \>=25% from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \>10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 16.7 monthsTTNT was defined as the time from the date of first dose administration to the date of the first dose initiation of the next line of antineoplastic therapy, for any reason.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 16.7 monthsPopulation: The Response-Evaluable Analysis Set was a subset of SAS including participants with measurable disease at baseline and at least 1 post-baseline efficacy evaluation. Due to early termination of the study no participants were enrolled in Group 2 Arm 4: modakafusp alfa + bortezomib and Group 3 arms, thus they are not presented here. Also, no participants in Group 1 fulfilled the criteria for the Response-Evaluable Analysis Set and hence are not presented here.
DCR was defined as the percentage of participants who achieved a stable disease (SD) or better during the study based on the investigator's disease assessment as defined by IMWG uniform response criteria. SD was defined as no known evidence of progressive disease or new bone lesions. Percentages were rounded off to the nearest single decimal place.
Outcome measures
| Measure |
Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg
n=4 Participants
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W, in combination with 10 mg lenalidomide capsules orally once daily continuously on Days 1 to 28, in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or to a maximum of 2 years for MRD \[-\] negative participants, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg
n=4 Participants
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 2 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg
n=3 Participants
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 4 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 20/70 milligrams per meter square (mg/m\^2) carfilzomib IV, on Day 1, 8 and 15 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
|---|---|---|---|---|
|
Groups 2 and 3: Disease Control Rate (DCR)
|
75.0 percentage of participants
Interval 19.41 to 99.37
|
50.0 percentage of participants
Interval 6.76 to 93.24
|
66.7 percentage of participants
Interval 9.43 to 99.16
|
—
|
SECONDARY outcome
Timeframe: Up to 16.7 monthsEFS was defined as the time from the date on which the first dose of study drug is administered to the date of the first documentation of an event that may include confirmed PD, discontinuation of a treatment for an AE (related or not related), or death due to any cause, whichever occurs first. PD was determined by IMWG criteria. PD: increase of \>=25 % from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \> 10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 16.7 monthsTTR was defined as the time from the date of the first dose administration to the date of the first documentation of objective confirmed response as defined by IMWG criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 6 months, 1 year, and 2 years after the start of treatmentPopulation: MRD data was not collected as no participant achieved the criteria for MRD-evaluable analysis set (i.e., being on study at 6 months).
Rate of MRD negativity at a sensitivity of 10\^-5 was defined as the percentage of participants who achieved MRD negative status in the MRD-evaluable analysis set.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 years after CR confirmationPopulation: MRD data was not collected as no participant achieved the criteria for MRD-evaluable analysis set (i.e., achieving a Complete Response).
Rate of MRD negativity CR status a sensitivity of 10\^-5 was defined as the percentage of participants who have achieved MRD negative CR status in participants achieving CR. CR is defined as negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow; in participants for whom only measurable disease is by serum FLC level, normal FLC ratio of 0.26 to 1.65 in addition to CR criteria is required.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 years after treatmentPopulation: MRD data was not collected as no participant achieved the criteria for MRD-evaluable analysis set (i.e., achieving a Complete Response).
Duration of MRD negativity (10\^-5) was defined as the time from the date of first documentation of MRD\[-\] to the first documentation of MRD positivity or confirmed PD or death due to any cause, whichever occurred first. PD: increase of \>=25% from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \>10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 16.7 monthsPopulation: MRD data was not collected as no participant achieved the criteria for MRD-evaluable analysis set (i.e., achieving a Complete Response).
Rate of MRD negativity at a sensitivity of 10\^-5 was defined as the percentage of participants who have achieved MRD negative status.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 16.7 monthsPopulation: MRD data was not collected as no participant achieved the criteria for MRD-evaluable analysis set (i.e., achieving a Complete Response).
Duration of MRD negativity (10\^-5) was defined as the time from the date of first documentation of MRD\[-\] to the first documentation of MRD positivity or confirmed PD or death due to any cause, whichever occurred first. PD: increase of \>=25% from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \>10 mg/dL; bone marrow plasma cell \>=10%; definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 16.7 monthsOutcome measures
Outcome data not reported
Adverse Events
Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 2 deaths
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg
n=3 participants at risk
Participants received 80 milligrams (mg) modakafusp alfa, infusion intravenously (IV), once on Day 1, once every 4 weeks (Q4W), in combination with 10 mg lenalidomide capsules orally once daily continuously on Days 1 to 28, in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or to a maximum of 2 years for measurable/minimal residual disease-negative (MRD \[-\]) participants, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg
n=4 participants at risk
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 2 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg
n=4 participants at risk
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 4 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2
n=3 participants at risk
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 20/70 milligrams per meter square (mg/m\^2) carfilzomib IV, on Day 1, 8 and 15 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
66.7%
2/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
Other adverse events
| Measure |
Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg
n=3 participants at risk
Participants received 80 milligrams (mg) modakafusp alfa, infusion intravenously (IV), once on Day 1, once every 4 weeks (Q4W), in combination with 10 mg lenalidomide capsules orally once daily continuously on Days 1 to 28, in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or to a maximum of 2 years for measurable/minimal residual disease-negative (MRD \[-\]) participants, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg
n=4 participants at risk
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 2 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg
n=4 participants at risk
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 4 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2
n=3 participants at risk
Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 20/70 milligrams per meter square (mg/m\^2) carfilzomib IV, on Day 1, 8 and 15 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.
|
|---|---|---|---|---|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
66.7%
2/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
2/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
50.0%
2/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
75.0%
3/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
100.0%
3/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
66.7%
2/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
50.0%
2/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
50.0%
2/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
General disorders
Chills
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Infections and infestations
Ear infection
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
50.0%
2/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
50.0%
2/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
66.7%
2/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
66.7%
2/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
66.7%
2/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
General disorders
Inflammation
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
66.7%
2/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
66.7%
2/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
66.7%
2/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
100.0%
3/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
75.0%
3/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
75.0%
3/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Gastrointestinal disorders
Noninfective sialoadenitis
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Infections and infestations
Salmonella bacteraemia
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
General disorders
Suprapubic pain
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
66.7%
2/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
75.0%
3/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
75.0%
3/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
100.0%
3/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
25.0%
1/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/4 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
0.00%
0/3 • Up to 16.7 months
The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.
|
Additional Information
Study Director
Takeda (Note: This product was divested to Teva Pharmaceuticals in 2025)
Phone: +1-877-825-3327
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place