Trial Outcomes & Findings for Study of Vorinostat (MK-0683) With Follicular Lymphoma (FL), Other Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL), or Mantle Cell Lymphoma (MCL) Participants (MK-0683-103) (NCT NCT00875056)
NCT ID: NCT00875056
Last Updated: 2026-01-30
Results Overview
ORR was defined as the percentage of participants who had a Complete Response (CR: Normal liver/spleen physical exam, all lymph nodes and nodal masses are normal, and there is no bone marrow involvement), a Complete Response/unconfirmed (CRu: Normal liver/spleen physical exam, plus at least a 75% decrease in the sum of the products of the greatest diameters of nodal masses if any are greater than 1.5 cm in their greatest diameter, normal or indeterminate bone marrow involvement), or a Partial Response (PR: Either normal physical exam, lymph nodes, and lymph node masses plus positive bone marrow involvement; OR normal physical exam or decrease in liver/spleen size plus at least a 50% decrease in the diameters of lymph nodes and nodal masses) as assessed using the international working group Non-Hodgkin's lymphoma standardized response criteria described by Cheson, BD in 1999. The percentage of participants who experienced a CR, CRu, or PR is presented.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
Up to 650 days
Results posted on
2026-01-30
Participant Flow
Participant milestones
| Measure |
Follicular Lymphoma (FL)
Participants with relapsed/refractory FL received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
|
Indolent Non-FL B-NHL or MCL
Participants with indolent non-follicular lymphoma (FL) B-cell non-Hodgkin's lymphoma (B-NHL), or with mantle cell Lymphoma (MCL) received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
|
Other Disease
Participants with disease other than relapsed/refractory follicular lymphoma (FL), non-FL B-cell non-Hodgkin's lymphoma (B-NHL), or mantle cell Lymphoma (MCL), as assessed by the Independent Central Pathological Committee, received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. This group was created to include participants who enrolled, but whose later diagnoses by the Independent Central Pathological Committee excluded them from analysis in the FL and non-FL B-NHL/MCL groups because they had different disease than those prespecified in the protocol.
|
|---|---|---|---|
|
Overall Study
STARTED
|
39
|
11
|
6
|
|
Overall Study
COMPLETED
|
5
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
34
|
9
|
6
|
Reasons for withdrawal
| Measure |
Follicular Lymphoma (FL)
Participants with relapsed/refractory FL received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
|
Indolent Non-FL B-NHL or MCL
Participants with indolent non-follicular lymphoma (FL) B-cell non-Hodgkin's lymphoma (B-NHL), or with mantle cell Lymphoma (MCL) received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
|
Other Disease
Participants with disease other than relapsed/refractory follicular lymphoma (FL), non-FL B-cell non-Hodgkin's lymphoma (B-NHL), or mantle cell Lymphoma (MCL), as assessed by the Independent Central Pathological Committee, received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. This group was created to include participants who enrolled, but whose later diagnoses by the Independent Central Pathological Committee excluded them from analysis in the FL and non-FL B-NHL/MCL groups because they had different disease than those prespecified in the protocol.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
8
|
1
|
2
|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
|
Overall Study
Progressive Disease
|
20
|
8
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
1
|
Baseline Characteristics
Study of Vorinostat (MK-0683) With Follicular Lymphoma (FL), Other Indolent B-cell Non-Hodgkin's Lymphoma (B-NHL), or Mantle Cell Lymphoma (MCL) Participants (MK-0683-103)
Baseline characteristics by cohort
| Measure |
Follicular Lymphoma (FL)
n=39 Participants
Participants with relapsed/refractory FL received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
|
Indolent Non-FL B-NHL or MCL
n=11 Participants
Participants with indolent non-follicular lymphoma (FL) B-cell non-Hodgkin's lymphoma (B-NHL), or with mantle cell Lymphoma (MCL) received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
|
Other Disease
n=6 Participants
Participants with disease other than relapsed/refractory follicular lymphoma (FL), non-FL B-cell non-Hodgkin's lymphoma (B-NHL), or mantle cell Lymphoma (MCL), as assessed by the Independent Central Pathological Committee, received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. This group was created to include participants who enrolled, but whose later diagnoses by the Independent Central Pathological Committee excluded them from analysis in the FL and non-FL B-NHL/MCL groups because they had different disease than those prespecified in the protocol.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.4 Years
STANDARD_DEVIATION 10.4 • n=41 Participants
|
62.9 Years
STANDARD_DEVIATION 9.7 • n=1581 Participants
|
56.3 Years
STANDARD_DEVIATION 10.5 • n=4626 Participants
|
58.4 Years
STANDARD_DEVIATION 10.4 • n=72 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
30 Participants
n=72 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=41 Participants
|
7 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
26 Participants
n=72 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=41 Participants
|
11 Participants
n=1581 Participants
|
6 Participants
n=4626 Participants
|
56 Participants
n=72 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
|
Race (NIH/OMB)
Asian
|
39 Participants
n=41 Participants
|
11 Participants
n=1581 Participants
|
6 Participants
n=4626 Participants
|
56 Participants
n=72 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
PRIMARY outcome
Timeframe: Up to 650 daysPopulation: The analysis population included all allocated participants with follicular lymphoma (FL), non-FL B cell non-Hodgkin's lymphoma (B-NHL), or mantle cell lymphoma (MCL) who received at least one dose of study drug, and had some post-allocation endpoint data.
ORR was defined as the percentage of participants who had a Complete Response (CR: Normal liver/spleen physical exam, all lymph nodes and nodal masses are normal, and there is no bone marrow involvement), a Complete Response/unconfirmed (CRu: Normal liver/spleen physical exam, plus at least a 75% decrease in the sum of the products of the greatest diameters of nodal masses if any are greater than 1.5 cm in their greatest diameter, normal or indeterminate bone marrow involvement), or a Partial Response (PR: Either normal physical exam, lymph nodes, and lymph node masses plus positive bone marrow involvement; OR normal physical exam or decrease in liver/spleen size plus at least a 50% decrease in the diameters of lymph nodes and nodal masses) as assessed using the international working group Non-Hodgkin's lymphoma standardized response criteria described by Cheson, BD in 1999. The percentage of participants who experienced a CR, CRu, or PR is presented.
Outcome measures
| Measure |
Follicular Lymphoma (FL)
n=39 Participants
Participants with relapsed/refractory FL received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
|
Indolent Non-FL B-NHL or MCL
n=11 Participants
Participants with indolent non-follicular lymphoma (FL) B-cell non-Hodgkin's lymphoma (B-NHL), or with mantle cell Lymphoma (MCL) received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
|
Other Disease
Participants with disease other than relapsed/refractory follicular lymphoma (FL), non-FL B-cell non-Hodgkin's lymphoma (B-NHL), or mantle cell Lymphoma (MCL), as assessed by the Independent Central Pathological Committee, received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. This group was created to include participants who enrolled, but whose later diagnoses by the Independent Central Pathological Committee excluded them from analysis in the FL and non-FL B-NHL/MCL groups because they had different disease than those prespecified in the protocol.
|
|---|---|---|---|
|
Objective Response Rate (ORR)
|
48.7 Percentage of participants
Interval 32.4 to 65.2
|
27.3 Percentage of participants
Interval 6.0 to 61.0
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 29 monthsPopulation: All allocated participants who received a dose of study drug were included in this analysis.
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE was presented.
Outcome measures
| Measure |
Follicular Lymphoma (FL)
n=39 Participants
Participants with relapsed/refractory FL received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
|
Indolent Non-FL B-NHL or MCL
n=11 Participants
Participants with indolent non-follicular lymphoma (FL) B-cell non-Hodgkin's lymphoma (B-NHL), or with mantle cell Lymphoma (MCL) received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
|
Other Disease
n=6 Participants
Participants with disease other than relapsed/refractory follicular lymphoma (FL), non-FL B-cell non-Hodgkin's lymphoma (B-NHL), or mantle cell Lymphoma (MCL), as assessed by the Independent Central Pathological Committee, received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. This group was created to include participants who enrolled, but whose later diagnoses by the Independent Central Pathological Committee excluded them from analysis in the FL and non-FL B-NHL/MCL groups because they had different disease than those prespecified in the protocol.
|
|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
39 Participants
|
11 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to 536 daysPopulation: All allocated participants who received a dose of study drug were included in this analysis.
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued from study drug due to an adverse event was reported.
Outcome measures
| Measure |
Follicular Lymphoma (FL)
n=39 Participants
Participants with relapsed/refractory FL received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
|
Indolent Non-FL B-NHL or MCL
n=11 Participants
Participants with indolent non-follicular lymphoma (FL) B-cell non-Hodgkin's lymphoma (B-NHL), or with mantle cell Lymphoma (MCL) received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
|
Other Disease
n=6 Participants
Participants with disease other than relapsed/refractory follicular lymphoma (FL), non-FL B-cell non-Hodgkin's lymphoma (B-NHL), or mantle cell Lymphoma (MCL), as assessed by the Independent Central Pathological Committee, received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. This group was created to include participants who enrolled, but whose later diagnoses by the Independent Central Pathological Committee excluded them from analysis in the FL and non-FL B-NHL/MCL groups because they had different disease than those prespecified in the protocol.
|
|---|---|---|---|
|
Number of Participants Who Discontinued Study Drug Due to Experiencing an Adverse Event (AE)
|
6 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 650 daysPopulation: The analysis population included all allocated participants with FL who received at least one dose of study drug, and had some post-allocation endpoint data.
Time to Treatment Failure is defined as the time from allocation until the date of any treatment failure, including documented disease progression, or discontinuation of the study medication for any reason. Data was censored on the efficacy data cutoff date of 25 February, 2011.
Outcome measures
| Measure |
Follicular Lymphoma (FL)
n=39 Participants
Participants with relapsed/refractory FL received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
|
Indolent Non-FL B-NHL or MCL
Participants with indolent non-follicular lymphoma (FL) B-cell non-Hodgkin's lymphoma (B-NHL), or with mantle cell Lymphoma (MCL) received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
|
Other Disease
Participants with disease other than relapsed/refractory follicular lymphoma (FL), non-FL B-cell non-Hodgkin's lymphoma (B-NHL), or mantle cell Lymphoma (MCL), as assessed by the Independent Central Pathological Committee, received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. This group was created to include participants who enrolled, but whose later diagnoses by the Independent Central Pathological Committee excluded them from analysis in the FL and non-FL B-NHL/MCL groups because they had different disease than those prespecified in the protocol.
|
|---|---|---|---|
|
Time to Treatment Failure for Relapsed/Refractory FL
|
323 Days
Interval 60.0 to
For time to treatment failure upper limit, not all participants had experienced a response by the time of efficacy data cutoff, making the data not available.
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 650 daysPopulation: The analysis population included all allocated participants with FL who received at least one dose of study drug, and had some post-allocation endpoint data.
Time to Response is defined as the time from allocation until the time of an initial response. Data was censored on the efficacy data cutoff date of 25 February, 2011.
Outcome measures
| Measure |
Follicular Lymphoma (FL)
n=39 Participants
Participants with relapsed/refractory FL received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
|
Indolent Non-FL B-NHL or MCL
Participants with indolent non-follicular lymphoma (FL) B-cell non-Hodgkin's lymphoma (B-NHL), or with mantle cell Lymphoma (MCL) received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
|
Other Disease
Participants with disease other than relapsed/refractory follicular lymphoma (FL), non-FL B-cell non-Hodgkin's lymphoma (B-NHL), or mantle cell Lymphoma (MCL), as assessed by the Independent Central Pathological Committee, received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. This group was created to include participants who enrolled, but whose later diagnoses by the Independent Central Pathological Committee excluded them from analysis in the FL and non-FL B-NHL/MCL groups because they had different disease than those prespecified in the protocol.
|
|---|---|---|---|
|
Time to Response for Relapsed/Refractory FL
|
NA Days
Median time to response not reached. For upper and lower limits, not all participants had experienced a response by the time of efficacy data cutoff, making the data not available.
|
—
|
—
|
Adverse Events
Follicular Lymphoma (FL)
Serious events: 15 serious events
Other events: 39 other events
Deaths: 9 deaths
Indolent Non-FL B-NHL or MCL
Serious events: 4 serious events
Other events: 11 other events
Deaths: 4 deaths
Other Disease
Serious events: 2 serious events
Other events: 6 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Follicular Lymphoma (FL)
n=39 participants at risk
Participants with relapsed/refractory FL received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
|
Indolent Non-FL B-NHL or MCL
n=11 participants at risk
Participants with indolent non-follicular lymphoma (FL) B-cell non-Hodgkin's lymphoma (B-NHL), or with mantle cell Lymphoma (MCL) received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
|
Other Disease
n=6 participants at risk
Participants with disease other than relapsed/refractory follicular lymphoma (FL), non-FL B-cell non-Hodgkin's lymphoma (B-NHL), or mantle cell Lymphoma (MCL), as assessed by the Independent Central Pathological Committee, received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. This group was created to include participants who enrolled, but whose later diagnoses by the Independent Central Pathological Committee excluded them from analysis in the FL and non-FL B-NHL/MCL groups because they had different disease than those prespecified in the protocol.
|
|---|---|---|---|
|
General disorders
Asthenia
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.1%
2/39 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Infections and infestations
H1N1 influenza
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Infections and infestations
Meningitis aseptic
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Infections and infestations
Pneumonia
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.1%
2/39 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Nervous system disorders
Dizziness
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Nervous system disorders
VIth nerve paralysis
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Vascular disorders
Deep vein thrombosis
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Vascular disorders
Embolism venous
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Hepatobiliary disorders
Bile duct stone
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Infections and infestations
Cystitis
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Infections and infestations
Influenza
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Infections and infestations
Parotitis
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Desmoid tumour
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
Other adverse events
| Measure |
Follicular Lymphoma (FL)
n=39 participants at risk
Participants with relapsed/refractory FL received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
|
Indolent Non-FL B-NHL or MCL
n=11 participants at risk
Participants with indolent non-follicular lymphoma (FL) B-cell non-Hodgkin's lymphoma (B-NHL), or with mantle cell Lymphoma (MCL) received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol.
|
Other Disease
n=6 participants at risk
Participants with disease other than relapsed/refractory follicular lymphoma (FL), non-FL B-cell non-Hodgkin's lymphoma (B-NHL), or mantle cell Lymphoma (MCL), as assessed by the Independent Central Pathological Committee, received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. This group was created to include participants who enrolled, but whose later diagnoses by the Independent Central Pathological Committee excluded them from analysis in the FL and non-FL B-NHL/MCL groups because they had different disease than those prespecified in the protocol.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
33.3%
13/39 • Number of events 40 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
63.6%
7/11 • Number of events 20 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Blood and lymphatic system disorders
Anaemia
|
30.8%
12/39 • Number of events 25 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
45.5%
5/11 • Number of events 11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Blood and lymphatic system disorders
Erythropenia
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 3 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Blood and lymphatic system disorders
Leukopenia
|
51.3%
20/39 • Number of events 107 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
72.7%
8/11 • Number of events 45 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
50.0%
3/6 • Number of events 11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Blood and lymphatic system disorders
Neutropenia
|
74.4%
29/39 • Number of events 177 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
63.6%
7/11 • Number of events 89 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
33.3%
2/6 • Number of events 7 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
94.9%
37/39 • Number of events 194 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
90.9%
10/11 • Number of events 79 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
83.3%
5/6 • Number of events 15 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Cardiac disorders
Palpitations
|
12.8%
5/39 • Number of events 6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Ear and labyrinth disorders
Tinnitus
|
5.1%
2/39 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Eye disorders
Asthenopia
|
5.1%
2/39 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
10.3%
4/39 • Number of events 9 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.7%
3/39 • Number of events 8 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.4%
6/39 • Number of events 7 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.8%
5/39 • Number of events 8 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Gastrointestinal disorders
Cheilitis
|
7.7%
3/39 • Number of events 7 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
18.2%
2/11 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Gastrointestinal disorders
Constipation
|
43.6%
17/39 • Number of events 33 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
36.4%
4/11 • Number of events 11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Gastrointestinal disorders
Dental caries
|
7.7%
3/39 • Number of events 3 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
71.8%
28/39 • Number of events 331 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
81.8%
9/11 • Number of events 131 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
83.3%
5/6 • Number of events 15 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Gastrointestinal disorders
Dry mouth
|
10.3%
4/39 • Number of events 10 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 3 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
3/39 • Number of events 6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
18.2%
2/11 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Gastrointestinal disorders
Enterocolitis
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Gastrointestinal disorders
Flatulence
|
5.1%
2/39 • Number of events 3 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Gastrointestinal disorders
Gastritis
|
10.3%
4/39 • Number of events 8 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.7%
3/39 • Number of events 3 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Gastrointestinal disorders
Nausea
|
61.5%
24/39 • Number of events 97 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
63.6%
7/11 • Number of events 12 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
50.0%
3/6 • Number of events 4 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Gastrointestinal disorders
Stomatitis
|
23.1%
9/39 • Number of events 29 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
13/39 • Number of events 50 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
33.3%
2/6 • Number of events 4 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
General disorders
Asthenia
|
15.4%
6/39 • Number of events 18 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
General disorders
Chest discomfort
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
General disorders
Chest pain
|
12.8%
5/39 • Number of events 7 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
General disorders
Chills
|
5.1%
2/39 • Number of events 4 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
General disorders
Face oedema
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
General disorders
Facial pain
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
General disorders
Fatigue
|
56.4%
22/39 • Number of events 104 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
45.5%
5/11 • Number of events 14 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
33.3%
2/6 • Number of events 4 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
General disorders
Influenza like illness
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
General disorders
Mucosal inflammation
|
7.7%
3/39 • Number of events 3 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
General disorders
Oedema
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
General disorders
Oedema peripheral
|
7.7%
3/39 • Number of events 3 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
General disorders
Puncture site pain
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
General disorders
Pyrexia
|
10.3%
4/39 • Number of events 4 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
25.6%
10/39 • Number of events 34 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
27.3%
3/11 • Number of events 10 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Infections and infestations
Influenza
|
7.7%
3/39 • Number of events 3 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Infections and infestations
Nasopharyngitis
|
48.7%
19/39 • Number of events 60 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
36.4%
4/11 • Number of events 15 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Infections and infestations
Oral herpes
|
2.6%
1/39 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Infections and infestations
Pharyngitis
|
5.1%
2/39 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Infections and infestations
Upper aerodigestive tract infection
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
17.9%
7/39 • Number of events 33 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
23.1%
9/39 • Number of events 9 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Injury, poisoning and procedural complications
Animal bite
|
10.3%
4/39 • Number of events 4 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Investigations
Alanine aminotransferase increased
|
28.2%
11/39 • Number of events 27 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Investigations
Aspartate aminotransferase increased
|
30.8%
12/39 • Number of events 27 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
36.4%
4/11 • Number of events 7 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Investigations
Blood bilirubin increased
|
7.7%
3/39 • Number of events 9 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
18.2%
2/11 • Number of events 4 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Investigations
Blood creatinine increased
|
25.6%
10/39 • Number of events 42 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
18.2%
2/11 • Number of events 7 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
33.3%
2/6 • Number of events 7 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Investigations
Blood lactate dehydrogenase increased
|
12.8%
5/39 • Number of events 9 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
18.2%
2/11 • Number of events 15 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
33.3%
2/6 • Number of events 7 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Investigations
Blood urea increased
|
10.3%
4/39 • Number of events 9 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Investigations
Weight decreased
|
28.2%
11/39 • Number of events 12 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
27.3%
3/11 • Number of events 3 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
69.2%
27/39 • Number of events 141 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
54.5%
6/11 • Number of events 15 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
50.0%
3/6 • Number of events 3 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
3/39 • Number of events 15 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
17.9%
7/39 • Number of events 22 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
27.3%
3/11 • Number of events 20 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
25.6%
10/39 • Number of events 21 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
36.4%
4/11 • Number of events 7 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.7%
3/39 • Number of events 13 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
27.3%
3/11 • Number of events 14 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
12.8%
5/39 • Number of events 22 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Metabolism and nutrition disorders
Hyperphosphatasaemia
|
5.1%
2/39 • Number of events 3 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.3%
4/39 • Number of events 25 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.3%
4/39 • Number of events 16 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.3%
4/39 • Number of events 12 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.7%
3/39 • Number of events 6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
25.6%
10/39 • Number of events 34 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 10 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
5.1%
2/39 • Number of events 7 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.3%
4/39 • Number of events 5 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
18.2%
2/11 • Number of events 3 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.3%
4/39 • Number of events 7 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
3/39 • Number of events 5 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Nervous system disorders
Dizziness
|
10.3%
4/39 • Number of events 4 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Nervous system disorders
Dysgeusia
|
35.9%
14/39 • Number of events 66 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
27.3%
3/11 • Number of events 5 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
50.0%
3/6 • Number of events 3 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Nervous system disorders
Headache
|
17.9%
7/39 • Number of events 12 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Nervous system disorders
Hyperaesthesia
|
2.6%
1/39 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Nervous system disorders
Hypoaesthesia
|
10.3%
4/39 • Number of events 4 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.1%
2/39 • Number of events 3 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.7%
3/39 • Number of events 5 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Nervous system disorders
Somnolence
|
5.1%
2/39 • Number of events 4 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Psychiatric disorders
Anxiety
|
5.1%
2/39 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Psychiatric disorders
Depression
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Psychiatric disorders
Insomnia
|
7.7%
3/39 • Number of events 4 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Renal and urinary disorders
Haematuria
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Renal and urinary disorders
Proteinuria
|
15.4%
6/39 • Number of events 13 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
18.2%
2/11 • Number of events 4 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
6/39 • Number of events 10 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
3/39 • Number of events 3 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.8%
5/39 • Number of events 8 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.3%
4/39 • Number of events 12 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
17.9%
7/39 • Number of events 16 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 4 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
48.7%
19/39 • Number of events 19 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
36.4%
4/11 • Number of events 4 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
33.3%
2/6 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Asteatosis
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
5.1%
2/39 • Number of events 3 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
20.5%
8/39 • Number of events 8 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
7.7%
3/39 • Number of events 3 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
16.7%
1/6 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.6%
1/39 • Number of events 3 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.1%
9/39 • Number of events 13 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
18.2%
2/11 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Vascular disorders
Hot flush
|
5.1%
2/39 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Vascular disorders
Hypertension
|
5.1%
2/39 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Gastrointestinal disorders
Toothache
|
5.1%
2/39 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
General disorders
Local swelling
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Hepatobiliary disorders
Cholelithiasis
|
7.7%
3/39 • Number of events 3 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
5.1%
2/39 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Infections and infestations
Conjunctivitis
|
7.7%
3/39 • Number of events 5 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Infections and infestations
Gingivitis
|
5.1%
2/39 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Infections and infestations
Periodontitis
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Infections and infestations
Sinusitis
|
5.1%
2/39 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
7.7%
3/39 • Number of events 3 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.1%
2/39 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
5.1%
2/39 • Number of events 2 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/11 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/39 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.6%
1/39 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
9.1%
1/11 • Number of events 1 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
0.00%
0/6 • Up to approximately 65 months
Non-serious adverse events and serious adverse events were counted starting at the time of a participant's first treatment and included all treated participants. All-Cause Mortality was counted starting from the time of a participant's enrollment and included all randomized participants.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER