Trial Outcomes & Findings for A Study of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Patients With Advanced Stage Classical Hodgkin Lymphoma, Who Are Relapsed/ Refractory or Who Are Not Eligible for Autologous Stem Cell Transplant, (NCT NCT03138499)
NCT ID: NCT03138499
Last Updated: 2024-01-10
Results Overview
Progression Free Survival (PFS) is defined as time from date of randomization to death, or disease progression per investigator assessment estimated using the Kaplan-Meier (KM) product-limit method.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
23 participants
Primary outcome timeframe
From randomization to date of death, or disease progression (up to approximately 45 months)
Results posted on
2024-01-10
Participant Flow
23 participants were randomized for study participation, 22 received at least 1 dose of study drug.
Participant milestones
| Measure |
Nivolumab + Brentuximab Vedotin (BV)
Nivolumab 360 mg IV every 3 weeks until progression or unacceptable toxicity (except for patients in CR who can discontinue at 2 years) plus BV 1.8 mg/kg IV every 3 weeks for up to 16 cycles, or until progression or unacceptable toxicity, whichever occurs first.
|
Brentuximab Vedotin (BV)
BV alone 1.8 mg/kg every 3 weeks for up to 16 cycles, or until disease progression or unacceptable toxicity, whichever occurs first
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
|
Overall Study
COMPLETED
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
9
|
10
|
Reasons for withdrawal
| Measure |
Nivolumab + Brentuximab Vedotin (BV)
Nivolumab 360 mg IV every 3 weeks until progression or unacceptable toxicity (except for patients in CR who can discontinue at 2 years) plus BV 1.8 mg/kg IV every 3 weeks for up to 16 cycles, or until progression or unacceptable toxicity, whichever occurs first.
|
Brentuximab Vedotin (BV)
BV alone 1.8 mg/kg every 3 weeks for up to 16 cycles, or until disease progression or unacceptable toxicity, whichever occurs first
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Participants withdrew consent
|
1
|
0
|
|
Overall Study
Participant discontinued study before treatment
|
0
|
1
|
|
Overall Study
Disease Progression
|
2
|
6
|
|
Overall Study
Study drug toxicity
|
2
|
2
|
|
Overall Study
Participant request to discontinue study treatment
|
1
|
1
|
|
Overall Study
Other reasons
|
2
|
0
|
Baseline Characteristics
A Study of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Patients With Advanced Stage Classical Hodgkin Lymphoma, Who Are Relapsed/ Refractory or Who Are Not Eligible for Autologous Stem Cell Transplant,
Baseline characteristics by cohort
| Measure |
Nivolumab + Brentuximab Vedotin (BV)
n=12 Participants
Nivolumab 360 mg IV every 3 weeks until progression or unacceptable toxicity (except for patients in CR who can discontinue at 2 years) plus BV 1.8 mg/kg IV every 3 weeks for up to 16 cycles, or until progression or unacceptable toxicity, whichever occurs first.
|
Brentuximab Vedotin (BV)
n=11 Participants
BV alone 1.8 mg/kg every 3 weeks for up to 16 cycles, or until disease progression or unacceptable toxicity, whichever occurs first
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.5 Years
STANDARD_DEVIATION 13.1 • n=99 Participants
|
42.3 Years
STANDARD_DEVIATION 16.1 • n=107 Participants
|
39.8 Years
STANDARD_DEVIATION 14.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
JAPANESE
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
ASIAN OTHER
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
OTHER
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From randomization to date of death, or disease progression (up to approximately 45 months)Population: All randomized participants
Progression Free Survival (PFS) is defined as time from date of randomization to death, or disease progression per investigator assessment estimated using the Kaplan-Meier (KM) product-limit method.
Outcome measures
| Measure |
Nivolumab + Brentuximab Vedotin (BV)
n=12 Participants
Nivolumab 360 mg IV every 3 weeks until progression or unacceptable toxicity (except for patients in CR who can discontinue at 2 years) plus BV 1.8 mg/kg IV every 3 weeks for up to 16 cycles, or until progression or unacceptable toxicity, whichever occurs first.
|
Brentuximab Vedotin (BV)
n=11 Participants
BV alone 1.8 mg/kg every 3 weeks for up to 16 cycles, or until disease progression or unacceptable toxicity, whichever occurs first
|
|---|---|---|
|
Progression Free Survival (PFS)
|
14.32 Months
Interval 10.12 to
Insufficient number of participants with events
|
7.93 Months
Interval 2.86 to
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From randomization up to approximately 45 monthsPopulation: All randomized participants
Complete Response Rate (CRR) is defined as the number of participants who have achieved complete response (Lugano 2014 classification) per investigator assessment. Complete response is considered a score of 1, 2, or 3. Per the Lugano criteria: Positron emission tomography (PET) negative scans are defined on the 5-point scale as scores of 1, 2, or 3 (where 1 = no uptake above background; 2 = uptake \</= mediastinum; and 3 = uptake \> mediastinum but \</= liver) and PET-positive scans, as scores of 4 or 5 (where 4 = uptake moderately higher than liver; 5 = uptake markedly higher than liver and/or new lesions). Response on PET scans should be reported as complete metabolic response (CMR) partial metabolic response (PMR), SMD (stable metabolic disease), or PMD (progressive metabolic disease).
Outcome measures
| Measure |
Nivolumab + Brentuximab Vedotin (BV)
n=12 Participants
Nivolumab 360 mg IV every 3 weeks until progression or unacceptable toxicity (except for patients in CR who can discontinue at 2 years) plus BV 1.8 mg/kg IV every 3 weeks for up to 16 cycles, or until progression or unacceptable toxicity, whichever occurs first.
|
Brentuximab Vedotin (BV)
n=11 Participants
BV alone 1.8 mg/kg every 3 weeks for up to 16 cycles, or until disease progression or unacceptable toxicity, whichever occurs first
|
|---|---|---|
|
Complete Response Rate (CRR):
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From randomization up to approximately 45 monthsPopulation: All randomized participants
Objective Response Rate (ORR) is defined as the number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) (Lugano 2014 classification) per investigator assessment. Complete response is considered a score of 1, 2, or 3. Partial response is considered a score of 4 or 5. Per the Lugano criteria: Positron emission tomography (PET) negative scans are defined on the 5-point scale as scores of 1, 2, or 3 (where 1 = no uptake above background; 2 = uptake \</= mediastinum; and 3 = uptake \> mediastinum but \</= liver) and PET-positive scans, as scores of 4 or 5 (where 4 = uptake moderately higher than liver; 5 = uptake markedly higher than liver and/or new lesions). Response on PET scans should be reported as complete metabolic response (CMR) partial metabolic response (PMR), SMD (stable metabolic disease), or PMD (progressive metabolic disease).
Outcome measures
| Measure |
Nivolumab + Brentuximab Vedotin (BV)
n=12 Participants
Nivolumab 360 mg IV every 3 weeks until progression or unacceptable toxicity (except for patients in CR who can discontinue at 2 years) plus BV 1.8 mg/kg IV every 3 weeks for up to 16 cycles, or until progression or unacceptable toxicity, whichever occurs first.
|
Brentuximab Vedotin (BV)
n=11 Participants
BV alone 1.8 mg/kg every 3 weeks for up to 16 cycles, or until disease progression or unacceptable toxicity, whichever occurs first
|
|---|---|---|
|
Objective Response Rate (ORR)
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From randomization to date of documented progression or death (up to approximately 45 months)Population: All randomized participants
The time from first response (Complete response (CR) or partial response (PR)) to the date of initial objectively documented progression (2014 Lugano classification) or death due to any cause per investigator assessment estimated using the Kaplan-Meier (KM) product-limit method. Complete response is considered a score of 1, 2, or 3. Partial response is considered a score of 4 or 5. Per the Lugano criteria: Positron emission tomography (PET) negative scans are defined on the 5-point scale as scores of 1, 2, or 3 (where 1 = no uptake above background; 2 = uptake \</= mediastinum; and 3 = uptake \> mediastinum but \</= liver) and PET-positive scans, as scores of 4 or 5 (where 4 = uptake moderately higher than liver; 5 = uptake markedly higher than liver and/or new lesions). Response on PET scans should be reported as complete metabolic response (CMR) partial metabolic response (PMR), SMD (stable metabolic disease), or PMD (progressive metabolic disease).
Outcome measures
| Measure |
Nivolumab + Brentuximab Vedotin (BV)
n=8 Participants
Nivolumab 360 mg IV every 3 weeks until progression or unacceptable toxicity (except for patients in CR who can discontinue at 2 years) plus BV 1.8 mg/kg IV every 3 weeks for up to 16 cycles, or until progression or unacceptable toxicity, whichever occurs first.
|
Brentuximab Vedotin (BV)
n=5 Participants
BV alone 1.8 mg/kg every 3 weeks for up to 16 cycles, or until disease progression or unacceptable toxicity, whichever occurs first
|
|---|---|---|
|
Duration of Response (DOR)
|
11.27 Months
Interval 7.39 to 11.27
|
7.00 Months
Interval 1.54 to
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From randomization to date of documented progression or death (up to approximately 45 months)Population: All randomized participants with objective response of complete response (CR)
Duration of complete response (DOR) is defined as the time from first complete response to the date of initial objectively documented progression (2014 Lugano classification) or death due to any cause per investigator assessment estimated using the Kaplan-Meier (KM) product-limit method. Complete response is considered a score of 1, 2, or 3. Per the Lugano criteria: Positron emission tomography (PET) negative scans are defined on the 5-point scale as scores of 1, 2, or 3 (where 1 = no uptake above background; 2 = uptake \</= mediastinum; and 3 = uptake \> mediastinum but \</= liver) and PET-positive scans, as scores of 4 or 5 (where 4 = uptake moderately higher than liver; 5 = uptake markedly higher than liver and/or new lesions). Response on PET scans should be reported as complete metabolic response (CMR) partial metabolic response (PMR), SMD (stable metabolic disease), or PMD (progressive metabolic disease).
Outcome measures
| Measure |
Nivolumab + Brentuximab Vedotin (BV)
n=4 Participants
Nivolumab 360 mg IV every 3 weeks until progression or unacceptable toxicity (except for patients in CR who can discontinue at 2 years) plus BV 1.8 mg/kg IV every 3 weeks for up to 16 cycles, or until progression or unacceptable toxicity, whichever occurs first.
|
Brentuximab Vedotin (BV)
n=3 Participants
BV alone 1.8 mg/kg every 3 weeks for up to 16 cycles, or until disease progression or unacceptable toxicity, whichever occurs first
|
|---|---|---|
|
Duration of Complete Response (DOCR)
|
7.85 Months
Insufficient number of participants with events
|
NA Months
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From randomization to the date of death (up to approximately 3 years 7 months)Population: All randomized participants
Overall Survival (OS) is defined as the time between the date of randomization and the date of death estimated using the Kaplan-Meier (KM) product-limit method
Outcome measures
| Measure |
Nivolumab + Brentuximab Vedotin (BV)
n=12 Participants
Nivolumab 360 mg IV every 3 weeks until progression or unacceptable toxicity (except for patients in CR who can discontinue at 2 years) plus BV 1.8 mg/kg IV every 3 weeks for up to 16 cycles, or until progression or unacceptable toxicity, whichever occurs first.
|
Brentuximab Vedotin (BV)
n=11 Participants
BV alone 1.8 mg/kg every 3 weeks for up to 16 cycles, or until disease progression or unacceptable toxicity, whichever occurs first
|
|---|---|---|
|
Overall Survival (OS)
|
NA Months
Interval 25.4 to
Insufficient number of participants with events
|
NA Months
Insufficient number of participants with events
|
Adverse Events
Nivolumab + Brentuximab Vedotin (BV)
Serious events: 6 serious events
Other events: 12 other events
Deaths: 1 deaths
Brentuximab Vedotin (BV)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nivolumab + Brentuximab Vedotin (BV)
n=12 participants at risk
Nivolumab 360 mg IV every 3 weeks until progression or unacceptable toxicity (except for patients in CR who can discontinue at 2 years) plus BV 1.8 mg/kg IV every 3 weeks for up to 16 cycles, or until progression or unacceptable toxicity, whichever occurs first.
|
Brentuximab Vedotin (BV)
n=10 participants at risk
BV alone 1.8 mg/kg every 3 weeks for up to 16 cycles, or until disease progression or unacceptable toxicity, whichever occurs first
|
|---|---|---|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
General disorders
Pyrexia
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Adenovirus infection
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Herpes zoster
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
16.7%
2/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Seizure
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Embolism
|
0.00%
0/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
Other adverse events
| Measure |
Nivolumab + Brentuximab Vedotin (BV)
n=12 participants at risk
Nivolumab 360 mg IV every 3 weeks until progression or unacceptable toxicity (except for patients in CR who can discontinue at 2 years) plus BV 1.8 mg/kg IV every 3 weeks for up to 16 cycles, or until progression or unacceptable toxicity, whichever occurs first.
|
Brentuximab Vedotin (BV)
n=10 participants at risk
BV alone 1.8 mg/kg every 3 weeks for up to 16 cycles, or until disease progression or unacceptable toxicity, whichever occurs first
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
2/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
20.0%
2/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
20.0%
2/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
30.0%
3/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Bradycardia
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Palpitations
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Tachycardia
|
16.7%
2/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Eye discharge
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Eye pruritus
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Scleral hyperaemia
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Vision blurred
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
41.7%
5/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
20.0%
2/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
4/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
40.0%
4/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
3/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
General disorders
Chest pain
|
16.7%
2/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
General disorders
Chills
|
25.0%
3/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
General disorders
Fatigue
|
50.0%
6/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
40.0%
4/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
General disorders
Influenza like illness
|
0.00%
0/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
General disorders
Malaise
|
0.00%
0/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
General disorders
Mucosal inflammation
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
General disorders
Non-cardiac chest pain
|
33.3%
4/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
General disorders
Pain
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
General disorders
Pyrexia
|
33.3%
4/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
20.0%
2/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Abscess jaw
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Body tinea
|
0.00%
0/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Cystitis
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Fungal skin infection
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Herpes zoster
|
16.7%
2/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Oral infection
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Rhinitis
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Scrotal abscess
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Sinusitis
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
2/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Viral infection
|
0.00%
0/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Viral pericarditis
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
2/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
2/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
20.0%
2/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
2/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
30.0%
3/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
20.0%
2/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood bilirubin decreased
|
0.00%
0/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood uric acid increased
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Investigations
Breath sounds abnormal
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Investigations
Ejection fraction decreased
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Investigations
Influenza B virus test positive
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Investigations
Lymphocyte count decreased
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
20.0%
2/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Investigations
Neutrophil count decreased
|
16.7%
2/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
20.0%
2/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Investigations
Platelet count decreased
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Investigations
Weight decreased
|
16.7%
2/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Investigations
Weight increased
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Investigations
White blood cell count decreased
|
16.7%
2/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
20.0%
2/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
2/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
2/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
25.0%
3/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
20.0%
2/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
16.7%
2/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
2/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
2/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
16.7%
2/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
20.0%
2/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
50.0%
6/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
20.0%
2/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
50.0%
6/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
60.0%
6/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
4/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
25.0%
3/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Depression
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
25.0%
3/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Urine odour abnormal
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
0.00%
0/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
41.7%
5/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
20.0%
2/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
2/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
4/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
25.0%
3/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
40.0%
4/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
2/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
30.0%
3/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
2/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
10.0%
1/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
8.3%
1/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypotension
|
16.7%
2/12 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
|
0.00%
0/10 • From first dose to up to 100 days post last dose (up to approximately 2 years) All-cause mortality was assessed from date of first dose to study completion (up to approximately 3 years 7 months)
23 participants were randomized for study participation, 22 received at least 1 dose of study drug and one participant discontinued study before treatment. Adverse events were collected for all treated participants who received at least 1 dose of study treatment.
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Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER