Trial Outcomes & Findings for Early or Delayed Fludarabine and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia (NCT NCT00513747)
NCT ID: NCT00513747
Last Updated: 2020-04-22
Results Overview
Kaplan-Meier analysis was conducted to estimate the distribution of time from randomization to second treatment or death whichever comes first. Events were defined as the start of second treatment or death. Patients who had not experienced one of these defined events of interest were censored at their last known follow-up.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
84 participants
Primary outcome timeframe
Up to 72 months
Results posted on
2020-04-22
Participant Flow
The Enrollment number in the Protocol Section does not match the number of participants who started in the Participant Flow due to limited data on one participant (i.e. the participant was registered but was not randomized or classified (high vs. low risk) because the participant withdrew consent for all follow-up the same day of registration).
Participant milestones
| Measure |
Arm A: High Risk Early Intervention
Randomized Patients receive 50, 325, and 375 mg/m\^2 rituximab IV over 4 hours on days 1, 3, and 5 of week 1, respectively; then patients receive 375 mg/m\^2 rituximab IV on day 1 of weeks 5, 9, 13,
\> 17, and 21. Patients also receive 25 mg/m\^2/day fludarabine monophosphate IV over 30 minutes on days 1-5 of weeks 1, 5, 9, 13, 17, and 21. After completion of chemoimmunotherapy, patients are followed every 3 months until disease progression. At the time of disease progression, patients receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
Arm B: High Risk Observation + Later Treatment
Randomized Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
Arm C: Low Risk Observation + Later Treatment
Patients who were registered to the low-risk arm may elect to provide continued follow-up information on their treatment, disease course, and outcome regardless of the medical therapy they and their physician select. Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
11
|
55
|
|
Overall Study
Received at Least One Dose of Treatment
|
9
|
11
|
40
|
|
Overall Study
COMPLETED
|
17
|
11
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early or Delayed Fludarabine and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Arm A: High Risk Early Intervention
n=17 Participants
Randomized Patients receive 50, 325, and 375 mg/m\^2 rituximab IV over 4 hours on days 1, 3, and 5 of week 1, respectively; then patients receive 375 mg/m\^2 rituximab IV on day 1 of weeks 5, 9, 13,\> 17, and 21. Patients also receive 25 mg/m\^2/day fludarabine monophosphate IV over 30 minutes on days 1-5 of weeks 1, 5, 9, 13, 17, and 21. After completion of chemoimmunotherapy, patients are followed every 3 months until disease progression. At the time of disease progression, patients receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
Arm B: High Risk Observation + Later Treatment
n=11 Participants
Randomized Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
Arm C: Low Risk Observation + Later Treatment
n=55 Participants
Patients who were registered to the low-risk arm may elect to provide continued follow-up information on their treatment, disease course, and outcome regardless of the medical therapy they and their physician select. Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
60 years
n=7 Participants
|
59 years
n=5 Participants
|
60 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 72 monthsPopulation: Randomized High Risk patients are included in this analysis.
Kaplan-Meier analysis was conducted to estimate the distribution of time from randomization to second treatment or death whichever comes first. Events were defined as the start of second treatment or death. Patients who had not experienced one of these defined events of interest were censored at their last known follow-up.
Outcome measures
| Measure |
Arm A: High Risk Early Intervention
n=17 Participants
Randomized Patients receive 50, 325, and 375 mg/m\^2 rituximab IV over 4 hours on days 1, 3, and 5 of week 1, respectively; then patients receive 375 mg/m\^2 rituximab IV on day 1 of weeks 5, 9, 13,\> 17, and 21. Patients also receive 25 mg/m\^2/day fludarabine monophosphate IV over 30 minutes on days 1-5 of weeks 1, 5, 9, 13, 17, and 21. After completion of chemoimmunotherapy, patients are followed every 3 months until disease progression. At the time of disease progression, patients receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
Arm B: High Risk Observation + Later Treatment
n=11 Participants
Randomized Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
Arm C: Low Risk Observation + Later Treatment
Patients who were registered to the low-risk arm may elect to provide continued follow-up information on their treatment, disease course, and outcome regardless of the medical therapy they and their physician select. Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
Total
Arm A + Arm B + Arm C patients
|
|---|---|---|---|---|
|
Time to Second Treatment in High Risk Patients
|
62.7 months
Interval 57.3 to 66.5
|
56.3 months
Interval 39.2 to 56.3
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 72 monthsPopulation: Randomized High Risk patients are included in this analysis.
Kaplan-Meier analysis was conducted to estimate disease free survival defined as:\> * Arm A: Time from randomization until Second Treatment (first relapse) or death whichever comes first. Events were defined as the start of second treatment or death. Patients who had not experienced one of these defined events of interest were censored at their last known follow-up.\> * Arm B: Time from randomization until First Treatment (first relapse) or death whichever comes first. Events were defined as the start of first treatment or death. Patients who had not experienced one of these defined events of interest were censored at their last known follow-up.
Outcome measures
| Measure |
Arm A: High Risk Early Intervention
n=17 Participants
Randomized Patients receive 50, 325, and 375 mg/m\^2 rituximab IV over 4 hours on days 1, 3, and 5 of week 1, respectively; then patients receive 375 mg/m\^2 rituximab IV on day 1 of weeks 5, 9, 13,\> 17, and 21. Patients also receive 25 mg/m\^2/day fludarabine monophosphate IV over 30 minutes on days 1-5 of weeks 1, 5, 9, 13, 17, and 21. After completion of chemoimmunotherapy, patients are followed every 3 months until disease progression. At the time of disease progression, patients receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
Arm B: High Risk Observation + Later Treatment
n=11 Participants
Randomized Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
Arm C: Low Risk Observation + Later Treatment
Patients who were registered to the low-risk arm may elect to provide continued follow-up information on their treatment, disease course, and outcome regardless of the medical therapy they and their physician select. Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
Total
Arm A + Arm B + Arm C patients
|
|---|---|---|---|---|
|
Disease-Free Survival in High Risk Patients
|
62.7 months
Interval 57.3 to 66.5
|
39.2 months
Interval 33.9 to
The 95% confidence interval upper limit was not evaluable (i.e. under the level of detection).
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 72 monthsPopulation: Randomized High Risk patients are included in this analysis.
Kaplan-Meier analysis was conducted to estimate the distribution of time from randomization to death from any cause. Estimates were not stratified. Patients who did not experience this primary outcome had their survival times censored at their last follow-up.
Outcome measures
| Measure |
Arm A: High Risk Early Intervention
n=17 Participants
Randomized Patients receive 50, 325, and 375 mg/m\^2 rituximab IV over 4 hours on days 1, 3, and 5 of week 1, respectively; then patients receive 375 mg/m\^2 rituximab IV on day 1 of weeks 5, 9, 13,\> 17, and 21. Patients also receive 25 mg/m\^2/day fludarabine monophosphate IV over 30 minutes on days 1-5 of weeks 1, 5, 9, 13, 17, and 21. After completion of chemoimmunotherapy, patients are followed every 3 months until disease progression. At the time of disease progression, patients receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
Arm B: High Risk Observation + Later Treatment
n=11 Participants
Randomized Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
Arm C: Low Risk Observation + Later Treatment
Patients who were registered to the low-risk arm may elect to provide continued follow-up information on their treatment, disease course, and outcome regardless of the medical therapy they and their physician select. Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
Total
Arm A + Arm B + Arm C patients
|
|---|---|---|---|---|
|
Overall Survival (OS) for High Risk Patients
|
NA months
The median and 95% confidence interval are not evaluable (i.e. under the level of detection).
|
NA months
Interval 39.2 to
The median and 95% confidence interval upper limit are not evaluable (i.e. under the level of detection).
|
—
|
—
|
SECONDARY outcome
Timeframe: Once at baselinePopulation: All patients are included in this analysis.
Number of patients with mutated and unmutated IgVH genes are reported below.
Outcome measures
| Measure |
Arm A: High Risk Early Intervention
n=17 Participants
Randomized Patients receive 50, 325, and 375 mg/m\^2 rituximab IV over 4 hours on days 1, 3, and 5 of week 1, respectively; then patients receive 375 mg/m\^2 rituximab IV on day 1 of weeks 5, 9, 13,\> 17, and 21. Patients also receive 25 mg/m\^2/day fludarabine monophosphate IV over 30 minutes on days 1-5 of weeks 1, 5, 9, 13, 17, and 21. After completion of chemoimmunotherapy, patients are followed every 3 months until disease progression. At the time of disease progression, patients receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
Arm B: High Risk Observation + Later Treatment
n=11 Participants
Randomized Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
Arm C: Low Risk Observation + Later Treatment
n=55 Participants
Patients who were registered to the low-risk arm may elect to provide continued follow-up information on their treatment, disease course, and outcome regardless of the medical therapy they and their physician select. Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
Total
n=83 Participants
Arm A + Arm B + Arm C patients
|
|---|---|---|---|---|
|
Number of Patients With Mutated and Unmutated IgVH Genes
Unmutated
|
17 Participants
|
11 Participants
|
0 Participants
|
28 Participants
|
|
Number of Patients With Mutated and Unmutated IgVH Genes
Mutated
|
0 Participants
|
0 Participants
|
55 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: Up to 72 monthsPopulation: Low Risk patients are included in this analysis.
Overall survival in low risk patients (registration to first treatment or death)\> • Events were defined as death from any cause. Low risk Patients who were alive were censored at their last known follow-up.
Outcome measures
| Measure |
Arm A: High Risk Early Intervention
n=55 Participants
Randomized Patients receive 50, 325, and 375 mg/m\^2 rituximab IV over 4 hours on days 1, 3, and 5 of week 1, respectively; then patients receive 375 mg/m\^2 rituximab IV on day 1 of weeks 5, 9, 13,\> 17, and 21. Patients also receive 25 mg/m\^2/day fludarabine monophosphate IV over 30 minutes on days 1-5 of weeks 1, 5, 9, 13, 17, and 21. After completion of chemoimmunotherapy, patients are followed every 3 months until disease progression. At the time of disease progression, patients receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
Arm B: High Risk Observation + Later Treatment
Randomized Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
Arm C: Low Risk Observation + Later Treatment
Patients who were registered to the low-risk arm may elect to provide continued follow-up information on their treatment, disease course, and outcome regardless of the medical therapy they and their physician select. Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
Total
Arm A + Arm B + Arm C patients
|
|---|---|---|---|---|
|
Overall Survival in Low Risk Patients
|
58.1 months
Interval 58.1 to
The 95% confidence interval upper limit was not evaluable (i.e. under the level of detection).
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 72 monthsPopulation: Low Risk patients are included in this analysis.
Time to First Treatment Survival in low risk patients (registration to first treatment or death)\> • Events were defined as the start of first treatment or death from any cause. Patients who didn't receive their first treatment were censored at their last known follow-up.
Outcome measures
| Measure |
Arm A: High Risk Early Intervention
n=55 Participants
Randomized Patients receive 50, 325, and 375 mg/m\^2 rituximab IV over 4 hours on days 1, 3, and 5 of week 1, respectively; then patients receive 375 mg/m\^2 rituximab IV on day 1 of weeks 5, 9, 13,\> 17, and 21. Patients also receive 25 mg/m\^2/day fludarabine monophosphate IV over 30 minutes on days 1-5 of weeks 1, 5, 9, 13, 17, and 21. After completion of chemoimmunotherapy, patients are followed every 3 months until disease progression. At the time of disease progression, patients receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
Arm B: High Risk Observation + Later Treatment
Randomized Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
Arm C: Low Risk Observation + Later Treatment
Patients who were registered to the low-risk arm may elect to provide continued follow-up information on their treatment, disease course, and outcome regardless of the medical therapy they and their physician select. Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
Total
Arm A + Arm B + Arm C patients
|
|---|---|---|---|---|
|
Time to First Treatment Survival in Low Risk Patients
|
58.1 months
Interval 58.1 to 70.3
|
—
|
—
|
—
|
Adverse Events
Arm A: High Risk Early Intervention
Serious events: 0 serious events
Other events: 9 other events
Deaths: 1 deaths
Arm B: High Risk Observation + Later Treatment
Serious events: 0 serious events
Other events: 11 other events
Deaths: 2 deaths
Arm C: Low Risk Observation + Later Treatment
Serious events: 0 serious events
Other events: 40 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A: High Risk Early Intervention
n=9 participants at risk
Randomized Patients receive 50, 325, and 375 mg/m\^2 rituximab IV over 4 hours on days 1, 3, and 5 of week 1, respectively; then patients receive 375 mg/m\^2 rituximab IV on day 1 of weeks 5, 9, 13, \> 17, and 21. Patients also receive 25 mg/m\^2/day fludarabine monophosphate IV over 30 minutes on days 1-5 of weeks 1, 5, 9, 13, 17, and 21. After completion of chemoimmunotherapy, patients are followed every 3 months until disease progression. At the time of disease progression, patients receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
Arm B: High Risk Observation + Later Treatment
n=11 participants at risk
Randomized Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
Arm C: Low Risk Observation + Later Treatment
n=40 participants at risk
Patients who were registered to the low-risk arm may elect to provide continued follow-up information on their treatment, disease course, and outcome regardless of the medical therapy they and their physician select. Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in Arm A. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
5.0%
2/40 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/40 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
1/9 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
5.0%
2/40 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 3 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
5.0%
2/40 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Gastrointestinal disorders
Nausea
|
44.4%
4/9 • Number of events 8 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
5.0%
2/40 • Number of events 3 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
5.0%
2/40 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
General disorders
Chest pain
|
11.1%
1/9 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
5.0%
2/40 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
General disorders
Chills
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/40 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
General disorders
Fatigue
|
100.0%
9/9 • Number of events 32 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
81.8%
9/11 • Number of events 30 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
47.5%
19/40 • Number of events 70 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
General disorders
General symptom
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
General disorders
Pain
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
7.5%
3/40 • Number of events 3 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Immune system disorders
Hypersensitivity
|
11.1%
1/9 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/40 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Bladder infection(gr 0/1/2 ANC)
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Bronchitis(gr 0/1/2 ANC)
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Bronchitis(gr 3/4 ANC)
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
5.0%
2/40 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Gastric infection(gr 0/1/2 ANC)
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Gingival infection(gr 0/1/2 ANC)
|
11.1%
1/9 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/40 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Infection(gr 0/1/2 ANC)
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Infectious colitis(gr 0/1/2 ANC)
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Infectious meningitis(gr 0/1/2 ANC)
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/40 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Laryngitis(gr 0/1/2 ANC)
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Lip infection(gr 0/1/2 ANC)
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Otitis externa(unknown ANC)
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Pharyngitis(gr 3/4 ANC)
|
11.1%
1/9 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/40 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Blood and lymphatic system disorders
Blood disorder
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
12.5%
5/40 • Number of events 17 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.1%
1/9 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/40 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
77.8%
7/9 • Number of events 25 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
45.5%
5/11 • Number of events 16 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
40.0%
16/40 • Number of events 43 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Cardiac disorders
Atrial fibrillation
|
11.1%
1/9 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/40 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Cardiac disorders
Myocardial ischemia
|
11.1%
1/9 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/40 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/40 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/40 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/40 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 3 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/40 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Pneumonia(gr 0/1/2 ANC)
|
11.1%
1/9 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Rhinitis infective(unknown ANC)
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Sinusitis(gr 0/1/2 ANC)
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
15.0%
6/40 • Number of events 7 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Sinusitis(unknown ANC)
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
5.0%
2/40 • Number of events 3 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Skin infection
|
22.2%
2/9 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Skin infection(gr 3/4 ANC)
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Skin infection(unknown ANC)
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Soft tissue infection(gr 3/4 ANC)
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Tooth infection(unknown ANC)
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Upper respiratory infection(gr 3/4 ANC)
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Upper respiratory infection(unknown ANC)
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Upper respiratory infectn(gr 0/1/2 ANC)
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
17.5%
7/40 • Number of events 7 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Ureteritis(unknown ANC)
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 3 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 6 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Urinary tract infection(gr 0/1/2 ANC)
|
11.1%
1/9 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
10.0%
4/40 • Number of events 5 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Urinary tract infection(gr 3/4 ANC)
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Urinary tract infection(unknown ANC)
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Infections and infestations
Vaginal infection(unknown ANC)
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
1/9 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
5.0%
2/40 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
5.0%
2/40 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Investigations
Creatinine increased
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Investigations
Laboratory test abnormal
|
11.1%
1/9 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Investigations
Leukocyte count decreased
|
44.4%
4/9 • Number of events 6 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Investigations
Lymphocyte count decreased
|
44.4%
4/9 • Number of events 16 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Investigations
Neutrophil count decreased
|
77.8%
7/9 • Number of events 21 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
18.2%
2/11 • Number of events 5 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
20.0%
8/40 • Number of events 22 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Investigations
Platelet count decreased
|
55.6%
5/9 • Number of events 21 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
36.4%
4/11 • Number of events 17 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
35.0%
14/40 • Number of events 55 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Investigations
Serum cholesterol increased
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
5.0%
2/40 • Number of events 3 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Investigations
Weight gain
|
11.1%
1/9 • Number of events 3 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/40 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Investigations
Weight loss
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Metabolism and nutrition disorders
Anorexia
|
11.1%
1/9 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/40 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
27.3%
3/11 • Number of events 3 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
7.5%
3/40 • Number of events 11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 14 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
5.0%
2/40 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
1/9 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
5.0%
2/40 • Number of events 3 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • Number of events 4 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
7.5%
3/40 • Number of events 5 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/40 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
5.0%
2/40 • Number of events 4 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
1/9 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Musculoskeletal and connective tissue disorders
Upper extremity dysfunction
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Nervous system disorders
Headache
|
22.2%
2/9 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 3 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
5.0%
2/40 • Number of events 4 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Nervous system disorders
Neurological disorder NOS
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Nervous system disorders
Syncope
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Nervous system disorders
Tremor
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/40 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Psychiatric disorders
Confusion
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 4 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Psychiatric disorders
Depression
|
11.1%
1/9 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
36.4%
4/11 • Number of events 24 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • Number of events 3 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
18.2%
2/11 • Number of events 5 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
5.0%
2/40 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Renal and urinary disorders
Urogenital disorder
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/40 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
11.1%
1/9 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
5.0%
2/40 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
11.1%
1/9 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/40 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
18.2%
2/11 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
1/9 • Number of events 5 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
45.5%
5/11 • Number of events 14 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
12.5%
5/40 • Number of events 5 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.1%
1/9 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/40 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
11.1%
1/9 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/40 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 3 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/40 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
22.2%
2/9 • Number of events 6 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
18.2%
2/11 • Number of events 6 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
5.0%
2/40 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
7.5%
3/40 • Number of events 4 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
18.2%
2/11 • Number of events 3 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Vascular disorders
Hot flashes
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
9.1%
1/11 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
5.0%
2/40 • Number of events 4 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
5.0%
2/40 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Vascular disorders
Hypotension
|
22.2%
2/9 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
5.0%
2/40 • Number of events 2 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
|
Vascular disorders
Thrombosis
|
0.00%
0/9 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
0.00%
0/11 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
2.5%
1/40 • Number of events 1 • Up to 72 months
Participants who received at least one dose of treatment are evaluable for adverse events (AEs) (i.e. summarized in the Serious and Other(Not Including Serious) AEs tables). All participants are followed for their survival status (i.e. summarized in the All-Cause Mortality table).
|
Additional Information
John Byrd, MD
The Arthur James Comprehensive Cancer Center
Phone: 614-293-9869
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place