Trial Outcomes & Findings for Daratumumab Based Response Adapted Therapy for Older Adults With Newly Diagnosed Multiple Myeloma (NCT NCT04151667)

Last Updated: 2025-12-26

Results Overview

Overall Response Rate of the response adapted strategy using the uniform response criteria of the International Myeloma Working Group (IMWG). Stringent Complete Response (sCR): Below plus normal FLC ratio and absence of clonal cells in bone marrow3 by immunohistochemistry or immunofluorescence Complete Response (CR): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \> 90% reduction in serum M-protein plus urine M-protein level \< 100 mg/24 h Partial Response (PR): \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \< 200 mg/24 h Minimal Response (MR): 25%-49% reduction of serum M-protein and 50%-89% reduction in 24 hours urinary M-protein Stable Disease (SD): Not meeting criteria for sCR, CR, VGPR, PR, MR, or Progressive Disease (PD)

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

Up to 8 months

Results posted on

2025-12-26

Participant Flow

Participant milestones

Participant milestones
Measure	A: Daratumumab & Dexamethasone All participants will receive 1800 mg in 15 ml Daratumumab by subcutaneous injection weekly and be given 20 mg of Dexamethasone orally once a week for 2 months. Patients who receive a partial response or better will continue on this arm. Daratumumab Injection: Patient will receive daratumumab (1800 mg in 15 ml) administered by manual subcutaneous injections weekly for the first 8 weeks, every other week for the next 16 weeks and every 4 weeks after. Dexamethasone Oral: The dexamethasone starting dose will be 20 mg PO once a week. Commercial dexamethasone will be used. Dexamethasone is often supplied in 4 mg tablets. Accordingly, patients will take 5 (4 mg tablets) one day of the week prior to the administration of daratumumab if this corresponds to a daratumumab dosing days. In non daratumumab dosing days, dexamethasone will be taken by the patient at home, usually in the morning with breakfast.	B: Daratumumab, Dexamethasone and Lenalidomide Participants who have less than a partial response to Arm A may have Lenalidomide added to their treatment. Lenalidomide will be given orally on days 1-21 of each 28 day treatment cycle. Daratumumab Injection: Patient will receive daratumumab (1800 mg in 15 ml) administered by manual subcutaneous injections weekly for the first 8 weeks, every other week for the next 16 weeks and every 4 weeks after. Dexamethasone Oral: The dexamethasone starting dose will be 20 mg PO once a week. Patients will take 5 (4 mg tablets) one day of the week prior to the administration of daratumumab if this corresponds to daratumumab dosing days. Non daratumumab dosing days, dexamethasone will be taken by the patient at home. Lenalidomide Pill: Lenalidomide will be given orally on days 1-21 of a 28 days cycle. The starting dose of lenalidomide will be based on the patient creatinine clearance per the package insert. Specifically patients with a creatinine clearance ≥ 50 ml/min will receive 25 mg of lenalidomide PO Days 1-21. Patients with a creatinine clearance ≥ 30 but less than 50 ml/min will receive 10 mg of lenalidomide. Patients with a creatinine clearance \< 30 ml/min are not eligible. Patients who experience a deterioration in renal function during screening or treatment may continue on lenalidomide therapy as long as the risk / benefit profile is deemed acceptable after discussion with the study principal investigator / sponsor.	C: Daratumumab, Dexamethasone and Bortezomib Participants who have less than a partial response to Arm A may have Bortezomib added to their treatment. Bortezomib will be given weekly in subcutaneous injections at a starting dose of 1/3 mg/m\^2 Days 1,8 and 15 of each 28 day treatment cycle. Daratumumab Injection: Patient will receive daratumumab (1800 mg in 15 ml) administered by manual subcutaneous injections weekly for the first 8 weeks, every other week for the next 16 weeks and every 4 weeks after. Dexamethasone Oral: The dexamethasone starting dose will be 20 mg PO once a week. Commercial dexamethasone will be used. Dexamethasone is often supplied in 4 mg tablets. Accordingly, patients will take 5 (4 mg tablets) one day of the week prior to the administration of daratumumab if this corresponds to a daratumumab dosing days. In non daratumumab dosing days, dexamethasone will be taken by the patient at home, usually in the morning with breakfast. Bortezomib Injection: Bortezomib will be given weekly subcutaneously in an effort to decrease the toxicity of the therapy. Specifically patients will receive a starting dose of bortezomib of 1.3 mg/m\^2 Days 1,8,15 of a 28 day cycle. Bortezomib will be administered in the cancer center per standard of care procedures.
Overall Study STARTED	14	12	7
Overall Study COMPLETED	14	12	7
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Daratumumab Based Response Adapted Therapy for Older Adults With Newly Diagnosed Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A: Daratumumab & Dexamethasone n=14 Participants All participants will receive 1800 mg in 15 ml Daratumumab by subcutaneous injection weekly and be given 20 mg of Dexamethasone orally once a week for 2 months. Patients who receive a partial response or better will continue on this arm. Daratumumab Injection: Patient will receive daratumumab (1800 mg in 15 ml) administered by manual subcutaneous injections weekly for the first 8 weeks, every other week for the next 16 weeks and every 4 weeks after. Dexamethasone Oral: The dexamethasone starting dose will be 20 mg PO once a week. Commercial dexamethasone will be used. Dexamethasone is often supplied in 4 mg tablets. Accordingly, patients will take 5 (4 mg tablets) one day of the week prior to the administration of daratumumab if this corresponds to a daratumumab dosing days. In non daratumumab dosing days, dexamethasone will be taken by the patient at home, usually in the morning with breakfast.	B: Daratumumab, Dexamethasone and Lenalidomide n=12 Participants Participants who have less than a partial response to Arm A may have Lenalidomide added to their treatment. Lenalidomide will be given orally on days 1-21 of each 28 day treatment cycle. Daratumumab Injection: Patient will receive daratumumab (1800 mg in 15 ml) administered by manual subcutaneous injections weekly for the first 8 weeks, every other week for the next 16 weeks and every 4 weeks after. Dexamethasone Oral: The dexamethasone starting dose will be 20 mg PO once a week. Commercial dexamethasone will be used. Dexamethasone is often supplied in 4 mg tablets. Accordingly, patients will take 5 (4 mg tablets) one day of the week prior to the administration of daratumumab if this corresponds to a daratumumab dosing days. In non daratumumab dosing days, dexamethasone will be taken by the patient at home, usually in the morning with breakfast. Lenalidomide Pill: Lenalidomide will be given orally on days 1-21 of a 28 days cycle. Specifically patients with a creatinine clearance ≥ 50 ml/min will receive 25 mg of lenalidomide PO Days 1-21. Patients with a creatinine clearance ≥ 30 but less than 50 ml/min will receive 10 mg of lenalidomide. Patients with a creatinine clearance \< 30 ml/min are not eligible but patients who experience a deterioration in the renal function during screening or treatment may continue on lenalidomide therapy as long as the risk / benefit profile is deemed acceptable.	C: Daratumumab, Dexamethasone and Bortezomib n=7 Participants Participants who have less than a partial response to Arm A may have Bortezomib added to their treatment. Bortezomib will be given weekly in subcutaneous injections at a starting dose of 1/3 mg/m\^2 Days 1,8 and 15 of each 28 day treatment cycle. Daratumumab Injection: Patient will receive daratumumab (1800 mg in 15 ml) administered by manual subcutaneous injections weekly for the first 8 weeks, every other week for the next 16 weeks and every 4 weeks after. Dexamethasone Oral: The dexamethasone starting dose will be 20 mg PO once a week. Commercial dexamethasone will be used. Dexamethasone is often supplied in 4 mg tablets. Accordingly, patients will take 5 (4 mg tablets) one day of the week prior to the administration of daratumumab if this corresponds to a daratumumab dosing days. In non daratumumab dosing days, dexamethasone will be taken by the patient at home, usually in the morning with breakfast. Bortezomib Injection: Bortezomib will be given weekly subcutaneously in an effort to decrease the toxicity of the therapy. Specifically patients will receive a starting dose of bortezomib of 1.3 mg/m\^2 Days 1,8,15 of a 28 day cycle. Bortezomib will be administered in the cancer center per standard of care procedures.	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=219 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=219 Participants
Age, Categorical >=65 years	14 Participants n=30 Participants	12 Participants n=30 Participants	7 Participants n=60 Participants	33 Participants n=219 Participants
Sex: Female, Male Female	4 Participants n=30 Participants	8 Participants n=30 Participants	3 Participants n=60 Participants	15 Participants n=219 Participants
Sex: Female, Male Male	10 Participants n=30 Participants	4 Participants n=30 Participants	4 Participants n=60 Participants	18 Participants n=219 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=30 Participants	2 Participants n=30 Participants	1 Participants n=60 Participants	3 Participants n=219 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=30 Participants	10 Participants n=30 Participants	5 Participants n=60 Participants	29 Participants n=219 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants	0 Participants n=30 Participants	1 Participants n=60 Participants	1 Participants n=219 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=219 Participants
Race (NIH/OMB) Asian	0 Participants n=30 Participants	1 Participants n=30 Participants	0 Participants n=60 Participants	1 Participants n=219 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=219 Participants
Race (NIH/OMB) Black or African American	2 Participants n=30 Participants	1 Participants n=30 Participants	2 Participants n=60 Participants	5 Participants n=219 Participants
Race (NIH/OMB) White	12 Participants n=30 Participants	10 Participants n=30 Participants	5 Participants n=60 Participants	27 Participants n=219 Participants
Race (NIH/OMB) More than one race	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=219 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=219 Participants
Region of Enrollment United States	14 participants n=30 Participants	12 participants n=30 Participants	7 participants n=60 Participants	33 participants n=219 Participants

PRIMARY outcome

Timeframe: Up to 8 months

Population: Evaluable Participants

Outcome measures

Outcome measures
Measure	A: Daratumumab & Dexamethasone n=12 Participants All participants will receive 1800 mg in 15 ml Daratumumab by subcutaneous injection weekly and be given 20 mg of Dexamethasone orally once a week for 2 months. Patients who receive a partial response or better will continue on this arm. Daratumumab Injection: Patient will receive daratumumab (1800 mg in 15 ml) administered by manual subcutaneous injections weekly for the first 8 weeks, every other week for the next 16 weeks and every 4 weeks after. Dexamethasone Oral: The dexamethasone starting dose will be 20 mg PO once a week. Commercial dexamethasone will be used. Dexamethasone is often supplied in 4 mg tablets. Accordingly, patients will take 5 (4 mg tablets) one day of the week prior to the administration of daratumumab if this corresponds to a daratumumab dosing days. In non daratumumab dosing days, dexamethasone will be taken by the patient at home, usually in the morning with breakfast.	B: Daratumumab, Dexamethasone and Lenalidomide n=12 Participants Participants who have less than a partial response to Arm A may have Lenalidomide added to their treatment. Lenalidomide will be given orally on days 1-21 of each 28 day treatment cycle. Daratumumab Injection: Patient will receive daratumumab (1800 mg in 15 ml) administered by manual subcutaneous injections weekly for the first 8 weeks, every other week for the next 16 weeks and every 4 weeks after. Dexamethasone Oral: The dexamethasone starting dose will be 20 mg PO once a week. Patients will take 5 (4 mg tablets) one day of the week prior to the administration of daratumumab if this corresponds to daratumumab dosing days. Non daratumumab dosing days, dexamethasone will be taken by the patient at home. Lenalidomide Pill: Lenalidomide will be given orally on days 1-21 of a 28 days cycle. The starting dose of lenalidomide will be based on the patient creatinine clearance per the package insert. Specifically patients with a creatinine clearance ≥ 50 ml/min will receive 25 mg of lenalidomide PO Days 1-21. Patients with a creatinine clearance ≥ 30 but less than 50 ml/min will receive 10 mg of lenalidomide. Patients with a creatinine clearance \< 30 ml/min are not eligible. Patients who experience a deterioration in renal function during screening or treatment may continue on lenalidomide therapy as long as the risk / benefit profile is deemed acceptable after discussion with the study principal investigator / sponsor.	C: Daratumumab, Dexamethasone and Bortezomib n=7 Participants Participants who have less than a partial response to Arm A may have Bortezomib added to their treatment. Bortezomib will be given weekly in subcutaneous injections at a starting dose of 1/3 mg/m\^2 Days 1,8 and 15 of each 28 day treatment cycle. Daratumumab Injection: Patient will receive daratumumab (1800 mg in 15 ml) administered by manual subcutaneous injections weekly for the first 8 weeks, every other week for the next 16 weeks and every 4 weeks after. Dexamethasone Oral: The dexamethasone starting dose will be 20 mg PO once a week. Commercial dexamethasone will be used. Dexamethasone is often supplied in 4 mg tablets. Accordingly, patients will take 5 (4 mg tablets) one day of the week prior to the administration of daratumumab if this corresponds to a daratumumab dosing days. In non daratumumab dosing days, dexamethasone will be taken by the patient at home, usually in the morning with breakfast. Bortezomib Injection: Bortezomib will be given weekly subcutaneously in an effort to decrease the toxicity of the therapy. Specifically patients will receive a starting dose of bortezomib of 1.3 mg/m\^2 Days 1,8,15 of a 28 day cycle. Bortezomib will be administered in the cancer center per standard of care procedures.
Overall Response Rate Stringent Complete Response	1 Participants	1 Participants	0 Participants
Overall Response Rate Complete Response	1 Participants	1 Participants	0 Participants
Overall Response Rate Very Good Partial Response	7 Participants	9 Participants	5 Participants
Overall Response Rate Partial Response	3 Participants	1 Participants	1 Participants
Overall Response Rate Minimal Response	0 Participants	0 Participants	0 Participants
Overall Response Rate Stable Disease	0 Participants	0 Participants	1 Participants
Overall Response Rate Progressive Disease	0 Participants	0 Participants	0 Participants
Overall Response Rate Partial Response and Better	12 Participants	12 Participants	6 Participants

SECONDARY outcome

Timeframe: Up to 2 years

Progression Free Survival (PFS) from start of treatment to death of any cause, disease progression or relapse of the date of last follow-up, whichever comes first. he PFS will be estimated by the Kaplan-Meier method and 95% confidence interval (CI) will be computed by complementary log-log transformation. The 1 and 2 year PFS and 95% Confidence Intervals will be reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Overall Survival (OS) from start of treatment to death of any cause or the date of last follow-up, whichever comes first. OS will be estimated by the Kaplan-Meier method and 95% confidence interval will be computed by complementary log-log transformation. The 2 year OS and 95% CI will be reported.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At the end of Cycle 2 (each cycle is 28 days)

The number of participants who continue on Daratumumab and Dexamethasone after 2 cycles

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 8 months

The number of patients who are without minimal residual disease (MRD) using Next Generation Sequencing (NGS) will be estimated and the 95% confidence interval will be computed by the Clopper-Pearson method.

Outcome measures

Outcome data not reported

Adverse Events

A: Daratumumab & Dexamethasone

Serious events: 4 serious events

Other events: 31 other events

Deaths: 1 deaths

B: Daratumumab, Dexamethasone and Lenalidomide

Serious events: 6 serious events

Other events: 12 other events

Deaths: 1 deaths

C: Daratumumab, Dexamethasone and Bortezomib

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Rachid Baz

Moffitt Cancer Center

Phone: 813-745-3163

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	A: Daratumumab & Dexamethasone n=33 participants at risk All participants will receive 1800 mg in 15 ml Daratumumab by subcutaneous injection weekly and be given 20 mg of Dexamethasone orally once a week for 2 months. Patients who receive a partial response or better will continue on this arm. Daratumumab Injection: Patient will receive daratumumab (1800 mg in 15 ml) administered by manual subcutaneous injections weekly for the first 8 weeks, every other week for the next 16 weeks and every 4 weeks after. Dexamethasone Oral: The dexamethasone starting dose will be 20 mg PO once a week. Commercial dexamethasone will be used. Dexamethasone is often supplied in 4 mg tablets. Accordingly, patients will take 5 (4 mg tablets) one day of the week prior to the administration of daratumumab if this corresponds to a daratumumab dosing days. In non daratumumab dosing days, dexamethasone will be taken by the patient at home, usually in the morning with breakfast.	B: Daratumumab, Dexamethasone and Lenalidomide n=12 participants at risk Participants who have less than a partial response to Arm A may have Lenalidomide added to their treatment. Lenalidomide will be given orally on days 1-21 of each 28 day treatment cycle. Daratumumab Injection: Patient will receive daratumumab (1800 mg in 15 ml) administered by manual subcutaneous injections weekly for the first 8 weeks, every other week for the next 16 weeks and every 4 weeks after. Dexamethasone Oral: The dexamethasone starting dose will be 20 mg PO once a week. Commercial dexamethasone will be used. Dexamethasone is often supplied in 4 mg tablets. Accordingly, patients will take 5 (4 mg tablets) one day of the week prior to the administration of daratumumab if this corresponds to a daratumumab dosing days. In non daratumumab dosing days, dexamethasone will be taken by the patient at home, usually in the morning with breakfast. Lenalidomide Pill: Lenalidomide will be given orally on days 1-21 of a 28 days cycle. Specifically patients with a creatinine clearance ≥ 50 ml/min will receive 25 mg of lenalidomide PO Days 1-21. Patients with a creatinine clearance ≥ 30 but less than 50 ml/min will receive 10 mg of lenalidomide. Patients with a creatinine clearance \< 30 ml/min are not eligible but patients who experience a deterioration in the renal function during screening or treatment may continue on lenalidomide therapy as long as the risk / benefit profile is deemed acceptable.	C: Daratumumab, Dexamethasone and Bortezomib n=7 participants at risk Participants who have less than a partial response to Arm A may have Bortezomib added to their treatment. Bortezomib will be given weekly in subcutaneous injections at a starting dose of 1/3 mg/m\^2 Days 1,8 and 15 of each 28 day treatment cycle. Daratumumab Injection: Patient will receive daratumumab (1800 mg in 15 ml) administered by manual subcutaneous injections weekly for the first 8 weeks, every other week for the next 16 weeks and every 4 weeks after. Dexamethasone Oral: The dexamethasone starting dose will be 20 mg PO once a week. Commercial dexamethasone will be used. Dexamethasone is often supplied in 4 mg tablets. Accordingly, patients will take 5 (4 mg tablets) one day of the week prior to the administration of daratumumab if this corresponds to a daratumumab dosing days. In non daratumumab dosing days, dexamethasone will be taken by the patient at home, usually in the morning with breakfast. Bortezomib Injection: Bortezomib will be given weekly subcutaneously in an effort to decrease the toxicity of the therapy. Specifically patients will receive a starting dose of bortezomib of 1.3 mg/m\^2 Days 1,8,15 of a 28 day cycle. Bortezomib will be administered in the cancer center per standard of care procedures.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/33 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	0.00% 0/12 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	14.3% 1/7 • Number of events 1 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)
General disorders Fever	0.00% 0/33 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	0.00% 0/12 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	14.3% 1/7 • Number of events 1 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)
Respiratory, thoracic and mediastinal disorders Bronchial infection	0.00% 0/33 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	0.00% 0/12 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	14.3% 1/7 • Number of events 1 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)
Gastrointestinal disorders Gastric ulcer	0.00% 0/33 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	8.3% 1/12 • Number of events 1 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	0.00% 0/7 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)
Nervous system disorders Syncope	6.1% 2/33 • Number of events 2 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	0.00% 0/12 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	0.00% 0/7 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/33 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	8.3% 1/12 • Number of events 1 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	0.00% 0/7 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)
Infections and infestations Fracture	3.0% 1/33 • Number of events 1 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	8.3% 1/12 • Number of events 1 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	0.00% 0/7 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	3.0% 1/33 • Number of events 1 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	0.00% 0/12 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	0.00% 0/7 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)
Musculoskeletal and connective tissue disorders Back pain	3.0% 1/33 • Number of events 1 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	0.00% 0/12 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	0.00% 0/7 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)
Gastrointestinal disorders Diverticulitis	0.00% 0/33 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	8.3% 1/12 • Number of events 1 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	0.00% 0/7 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)
Nervous system disorders Stroke	0.00% 0/33 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	8.3% 1/12 • Number of events 1 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	0.00% 0/7 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)
Infections and infestations Infections and infestations - Other	3.0% 1/33 • Number of events 1 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	0.00% 0/12 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	0.00% 0/7 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)
Cardiac disorders Sinus bradycardia	0.00% 0/33 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	8.3% 1/12 • Number of events 1 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	0.00% 0/7 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)
Cardiac disorders Sick sinus syndrome	0.00% 0/33 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	8.3% 1/12 • Number of events 1 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	0.00% 0/7 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)
Infections and infestations COVID-19	3.0% 1/33 • Number of events 1 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	0.00% 0/12 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	0.00% 0/7 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)
Renal and urinary disorders Urinary tract infection	3.0% 1/33 • Number of events 1 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	8.3% 1/12 • Number of events 1 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	0.00% 0/7 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)
Injury, poisoning and procedural complications Hip fracture	3.0% 1/33 • Number of events 1 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	0.00% 0/12 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	0.00% 0/7 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other	0.00% 0/33 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	0.00% 0/12 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	14.3% 1/7 • Number of events 1 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)
Infections and infestations Lung infection	0.00% 0/33 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	8.3% 1/12 • Number of events 1 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)	0.00% 0/7 • Adverse Events are still being collected. Per Protocol, Adverse Events are collected from "On Treatment" date to 30 days after "Off Treatment" date (on average of 2 years)