Trial Outcomes & Findings for Japan Expansion Cohort: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma (NCT NCT06868667)

Last Updated: 2025-05-09

Results Overview

PFS is defined as time from randomization until earliest date of disease progression (PD), determined by Independent Review Committee (IRC), according to the International Myeloma Working Group (IMWG) Response Criteria, or death due to any cause. PD= increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5 grams per deciliter {g/dL}\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200 milligrams per 24 hours {mg/24h}\]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved serum free light chains (sFLC) levels \[absolute increase \>10mg/dL\]; appearance of new lesion,\>=50% increase from nadir in Sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1 centimeter (cm) in short axis.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

24 participants

Primary outcome timeframe

Up to approximately 32 months

Results posted on

2025-05-09

Participant Flow

The results presented are until the primary completion date. Additional results will be provided within a year of study completion.

Participant milestones

Participant milestones
Measure	Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) Japanese participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of each 21-day Cycle until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/meter\^2 (m\^2) Bor administered subcutaneously (SC) once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex via oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles.	Daratumumab + Bor + Dex Japanese participants with RRMM received 16 mg/kg Daratumumab IV infusion once weekly of each 21-day cycle in Cycle 1 to Cycle 3; once every 3 weeks on Day 1 of each 21-day cycle in Cycle 4 to Cycle 8; and once every 4 weeks on day 1 of each 28-day cycle from cycle 9 onwards until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/m\^2 Bor administered SC once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles.
Overall Study STARTED	10	14
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	10	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) Japanese participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of each 21-day Cycle until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/meter\^2 (m\^2) Bor administered subcutaneously (SC) once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex via oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles.	Daratumumab + Bor + Dex Japanese participants with RRMM received 16 mg/kg Daratumumab IV infusion once weekly of each 21-day cycle in Cycle 1 to Cycle 3; once every 3 weeks on Day 1 of each 21-day cycle in Cycle 4 to Cycle 8; and once every 4 weeks on day 1 of each 28-day cycle from cycle 9 onwards until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/m\^2 Bor administered SC once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles.
Overall Study Death	0	4
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	1	0
Overall Study Ongoing	9	9

Baseline Characteristics

Japan Expansion Cohort: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) n=10 Participants Japanese participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of each 21-day Cycle until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/meter\^2 (m\^2) Bor administered subcutaneously (SC) once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex via oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles.	Daratumumab + Bor + Dex n=14 Participants Japanese participants with RRMM received 16 mg/kg Daratumumab IV infusion once weekly of each 21-day cycle in Cycle 1 to Cycle 3; once every 3 weeks on Day 1 of each 21-day cycle in Cycle 4 to Cycle 8; and once every 4 weeks on day 1 of each 28-day cycle from cycle 9 onwards until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/m\^2 Bor administered SC once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles.	Total n=24 Participants Total of all reporting groups
Age, Continuous	67.9 YEARS STANDARD_DEVIATION 11.02 • n=5 Participants	70.9 YEARS STANDARD_DEVIATION 6.21 • n=7 Participants	69.6 YEARS STANDARD_DEVIATION 8.46 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	11 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 32 months

Population: Intent-to-Treat (ITT) Population included all randomized participants whether or not randomized treatment was administered.

Outcome measures

Outcome measures
Measure	Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) n=10 Participants Japanese participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of each 21-day Cycle until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/meter\^2 (m\^2) Bor administered subcutaneously (SC) once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex via oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles.	Daratumumab + Bor + Dex n=14 Participants Japanese participants with RRMM received 16 mg/kg Daratumumab IV infusion once weekly of each 21-day cycle in Cycle 1 to Cycle 3; once every 3 weeks on Day 1 of each 21-day cycle in Cycle 4 to Cycle 8; and once every 4 weeks on day 1 of each 28-day cycle from cycle 9 onwards until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/m\^2 Bor administered SC once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles.
Progression-free Survival (PFS)	NA Months Interval 7.0 to The median and upper limit of 95% Confidence Interval were not estimable due to the length of follow-up in assessing the number of events.	11.1 Months Interval 4.9 to The upper limit of 95% Confidence Interval was not estimable due to the length of follow-up in assessing the number of events.

SECONDARY outcome

Timeframe: Up to 255 weeks

OS is defined as time from the date of randomization until the date of death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 255 weeks

DOR is defined as time from first documented evidence of partial response or better until first documented progression or death, whichever occurs first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 255 weeks

Minimal Residual Disease (MRD) negativity rate is defined as the percentage of participants who are MRD negative by next generation sequencing (NGS).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 255 weeks

CRR is defined as percentage of participants with a confirmed complete response (CR) or better (i.e., CR, stringent Complete Response (sCR)).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 255 weeks

ORR is defined as percentage of participants with a confirmed partial response (PR) or better (i.e. PR, Very Good Partial Response \[VGPR\], CR or sCR).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 255 weeks

CBR is defined as percentage of participants with a confirmed minimal response (MR) or better per International Myeloma Working Group (IMWG).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 255 weeks

TTR is defined as time from the date of randomization and the first documented evidence of response (PR or better) among participants who achieve partial response or better.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 255 weeks

TTP is defined as the time from the date of randomization until the earliest date of documented PD or death due to PD. PD= increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5 grams per deciliter {g/dL}\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200 milligrams per 24 hours {mg/24h}\]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved serum free light chains (sFLC) levels \[absolute increase \>10mg/dL\]; appearance of new lesion,\>=50% increase from nadir in Sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1 centimeter (cm) in short axis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 255 weeks

PFS2 is defined as time from randomization to disease progression after initiation of new anti-myeloma therapy or death from any cause, whichever is earlier. If disease progression after new anti-myeloma therapy cannot be measured, a PFS event is defined as the date of discontinuation of new anti-myeloma therapy, or death from any cause, whichever is earlier

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 255 weeks

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 255 weeks

Blood samples will be collected for the analysis of hematology parameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 255 weeks

Blood samples will be collected for the analysis of clinical chemistry parameters.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 255 weeks

Urine samples will be collected for the urine dipstick analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 255 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 255 weeks

Blood samples will be collected for PK analysis of belantamab mafodotin.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 255 weeks

Blood samples will be collected for PK analysis of belantamab mafodotin.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 255 weeks

Blood samples will be collected for PK analysis of belantamab mafodotin.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 255 weeks

Serum samples will be collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be tested in screening assay, and positive samples will be further characterized for antibody titers.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 255 weeks

Serum samples will be collected for the analysis of the presence of ADAs using validated immunoassays. All samples will be further tested in screening assay, and positive samples will be further characterized for antibody titers.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 255 weeks

The PRO-CTCAE is a patient-reported outcome measure that was developed to evaluate symptomatic toxicities in patients in cancer clinical trials; it characterizes the frequency, severity, interference, and presence or absence of symptomatic toxicities. Responses ranges from 0 ("never," "none," "not at all," or "absent") to 4 ("almost constantly," "very severe," or "very much"), with a higher score indicating a higher frequency, severity, or interference of adverse events.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 255 weeks

The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included five functional scales (physical functioning \[PF\], role functioning \[RF\], cognitive functioning \[CF\], emotional functioning \[EF\] and social functioning \[SF\]), three symptom scales (fatigue, pain and nausea/vomiting \[N/V\]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhoea, insomnia, dyspnoea, appetite loss \[AL\] and financial difficulties \[FD\]). Response options are 1 to 4. Scores are averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 255 weeks

The EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module (QLQMY20) is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. For the EORTC IL52, disease symptoms domain of the QLQ-MY20 will be used for bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity. The individual component scores in the disease symptom domain are averaged and transformed linearly to a score ranging from 0 to100. A high score for disease symptoms represents a high level of symptomatology or problems.

Outcome measures

Outcome data not reported

Adverse Events

Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex)

Serious events: 7 serious events

Other events: 10 other events

Deaths: 0 deaths

Daratumumab + Bor + Dex

Serious events: 2 serious events

Other events: 14 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) n=10 participants at risk Japanese participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of each 21-day Cycle until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/meter\^2 (m\^2) Bor administered subcutaneously (SC) once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex via oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles.	Daratumumab + Bor + Dex n=14 participants at risk Japanese participants with RRMM received 16 mg/kg Daratumumab IV infusion once weekly of each 21-day cycle in Cycle 1 to Cycle 3; once every 3 weeks on Day 1 of each 21-day cycle in Cycle 4 to Cycle 8; and once every 4 weeks on day 1 of each 28-day cycle from cycle 9 onwards until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/m\^2 Bor administered SC once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles.
Infections and infestations COVID-19	20.0% 2/10 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion. Safety population included all randomized participants who took at least 1 dose of study treatment.	0.00% 0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion. Safety population included all randomized participants who took at least 1 dose of study treatment.
Infections and infestations Eyelid infection	10.0% 1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion. Safety population included all randomized participants who took at least 1 dose of study treatment.	0.00% 0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion. Safety population included all randomized participants who took at least 1 dose of study treatment.
Infections and infestations Pneumonia	10.0% 1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion. Safety population included all randomized participants who took at least 1 dose of study treatment.	0.00% 0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion. Safety population included all randomized participants who took at least 1 dose of study treatment.
Infections and infestations Pneumonia pneumococcal	10.0% 1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion. Safety population included all randomized participants who took at least 1 dose of study treatment.	0.00% 0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion. Safety population included all randomized participants who took at least 1 dose of study treatment.
Infections and infestations Sepsis	10.0% 1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion. Safety population included all randomized participants who took at least 1 dose of study treatment.	0.00% 0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion. Safety population included all randomized participants who took at least 1 dose of study treatment.
Infections and infestations Urinary tract infection	10.0% 1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion. Safety population included all randomized participants who took at least 1 dose of study treatment.	0.00% 0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion. Safety population included all randomized participants who took at least 1 dose of study treatment.
Blood and lymphatic system disorders Anaemia	0.00% 0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion. Safety population included all randomized participants who took at least 1 dose of study treatment.	7.1% 1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion. Safety population included all randomized participants who took at least 1 dose of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion. Safety population included all randomized participants who took at least 1 dose of study treatment.	7.1% 1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion. Safety population included all randomized participants who took at least 1 dose of study treatment.
Eye disorders Cataract	10.0% 1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion. Safety population included all randomized participants who took at least 1 dose of study treatment.	0.00% 0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion. Safety population included all randomized participants who took at least 1 dose of study treatment.
Gastrointestinal disorders Large intestine polyp	10.0% 1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion. Safety population included all randomized participants who took at least 1 dose of study treatment.	0.00% 0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion. Safety population included all randomized participants who took at least 1 dose of study treatment.
Musculoskeletal and connective tissue disorders Pathological fracture	10.0% 1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion. Safety population included all randomized participants who took at least 1 dose of study treatment.	0.00% 0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion. Safety population included all randomized participants who took at least 1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	10.0% 1/10 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion. Safety population included all randomized participants who took at least 1 dose of study treatment.	0.00% 0/14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion. Safety population included all randomized participants who took at least 1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion. Safety population included all randomized participants who took at least 1 dose of study treatment.	7.1% 1/14 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. The results presented are until the primary completion date. Additional results will be provided within a year of study completion. Safety population included all randomized participants who took at least 1 dose of study treatment.

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER