Trial Outcomes & Findings for Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma (NCT NCT02224781)
NCT ID: NCT02224781
Last Updated: 2026-02-18
Results Overview
Overall Survival (OS) was defined as the time from randomization to death from any cause. Patients who have not died would be censored at the date of last known alive. 2-year OS rate was defined as a proportion of patients who are alive after two years of follow-up time among all cases who have died within 2 years or alive after 2-year follow-up time. Kaplan-Meier method was used to estimate 2-year OS.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
267 participants
Primary outcome timeframe
assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry
Results posted on
2026-02-18
Participant Flow
The study was activated on July 13, 2015. The study was suspended between February 2 and April 11, 2016 due to a drug supply issue (acute shortage in the supply of Dabrafenib and Trametinib capsules) and closed to accrual on September 30, 2021 with a total accrual of 267 patients.
Participant milestones
| Measure |
Arm A (Immunotherapy)
IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity.
IMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm C.
Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.
Biospecimen Collection: Undergo collection of blood samples
Computed Tomography: Undergo CT
Echocardiography Test: Undergo ECHO
Ipilimumab: Given IV
Multigated Acquisition Scan: Undergo MUGA scan
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm B (BRAF Inhibitor Therapy)
Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm D.
Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.
Biospecimen Collection: Undergo collection of blood samples
Computed Tomography: Undergo CT
Dabrafenib Mesylate: Given PO
Echocardiography Test: Undergo ECHO
Multigated Acquisition Scan: Undergo MUGA scan
Quality-of-Life Assessment: Ancillary studies
Trametinib Dimethyl Sulfoxide: Given PO
|
|---|---|---|
|
Step 1
STARTED
|
135
|
132
|
|
Step 1
Treated
|
131
|
132
|
|
Step 1
COMPLETED
|
39
|
1
|
|
Step 1
NOT COMPLETED
|
96
|
131
|
|
Enrolled to Step 2
STARTED
|
30
|
52
|
|
Enrolled to Step 2
COMPLETED
|
0
|
10
|
|
Enrolled to Step 2
NOT COMPLETED
|
30
|
42
|
Reasons for withdrawal
| Measure |
Arm A (Immunotherapy)
IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity.
IMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm C.
Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.
Biospecimen Collection: Undergo collection of blood samples
Computed Tomography: Undergo CT
Echocardiography Test: Undergo ECHO
Ipilimumab: Given IV
Multigated Acquisition Scan: Undergo MUGA scan
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm B (BRAF Inhibitor Therapy)
Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm D.
Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.
Biospecimen Collection: Undergo collection of blood samples
Computed Tomography: Undergo CT
Dabrafenib Mesylate: Given PO
Echocardiography Test: Undergo ECHO
Multigated Acquisition Scan: Undergo MUGA scan
Quality-of-Life Assessment: Ancillary studies
Trametinib Dimethyl Sulfoxide: Given PO
|
|---|---|---|
|
Step 1
Never start protocol therapy
|
4
|
0
|
|
Step 1
Adverse Event
|
42
|
18
|
|
Step 1
Disease progression
|
33
|
83
|
|
Step 1
Death
|
7
|
4
|
|
Step 1
Withdrawal by Subject
|
1
|
7
|
|
Step 1
Other complicating disease
|
2
|
1
|
|
Step 1
Other
|
7
|
9
|
|
Step 1
Reason unknown
|
0
|
8
|
|
Step 1
Alternative therapy
|
0
|
1
|
|
Enrolled to Step 2
Adverse Event
|
4
|
12
|
|
Enrolled to Step 2
Disease progression
|
16
|
24
|
|
Enrolled to Step 2
Death
|
2
|
3
|
|
Enrolled to Step 2
Withdrawal by Subject
|
2
|
0
|
|
Enrolled to Step 2
Other reason
|
2
|
3
|
|
Enrolled to Step 2
On treatment
|
4
|
0
|
Baseline Characteristics
Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma
Baseline characteristics by cohort
| Measure |
Arm A (Immunotherapy)
n=135 Participants
IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity.
IMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm C.
Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.
Biospecimen Collection: Undergo collection of blood samples
Computed Tomography: Undergo CT
Echocardiography Test: Undergo ECHO
Ipilimumab: Given IV
Multigated Acquisition Scan: Undergo MUGA scan
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm B (BRAF Inhibitor Therapy)
n=132 Participants
Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm D.
Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.
Biospecimen Collection: Undergo collection of blood samples
Computed Tomography: Undergo CT
Dabrafenib Mesylate: Given PO
Echocardiography Test: Undergo ECHO
Multigated Acquisition Scan: Undergo MUGA scan
Quality-of-Life Assessment: Ancillary studies
Trametinib Dimethyl Sulfoxide: Given PO
|
Total
n=267 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=4 Participants
|
60 years
|
59 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=4 Participants
|
46 Participants
|
98 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=4 Participants
|
86 Participants
|
169 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
129 Participants
n=4 Participants
|
126 Participants
|
255 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-White
|
6 Participants
n=4 Participants
|
6 Participants
|
12 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entryPopulation: All randomized patients (ie, intent-to-treat population)
Overall Survival (OS) was defined as the time from randomization to death from any cause. Patients who have not died would be censored at the date of last known alive. 2-year OS rate was defined as a proportion of patients who are alive after two years of follow-up time among all cases who have died within 2 years or alive after 2-year follow-up time. Kaplan-Meier method was used to estimate 2-year OS.
Outcome measures
| Measure |
Arm A (Immunotherapy)
n=135 Participants
IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity.
IMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm C.
Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.
Biospecimen Collection: Undergo collection of blood samples
Computed Tomography: Undergo CT
Echocardiography Test: Undergo ECHO
Ipilimumab: Given IV
Multigated Acquisition Scan: Undergo MUGA scan
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm B (BRAF Inhibitor Therapy)
n=132 Participants
Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm D.
Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.
Biospecimen Collection: Undergo collection of blood samples
Computed Tomography: Undergo CT
Dabrafenib Mesylate: Given PO
Echocardiography Test: Undergo ECHO
Multigated Acquisition Scan: Undergo MUGA scan
Quality-of-Life Assessment: Ancillary studies
Trametinib Dimethyl Sulfoxide: Given PO
|
|---|---|---|
|
2-year Overall Survival (OS)
|
0.683 Proportion of participants
Interval 0.603 to 0.764
|
0.541 Proportion of participants
Interval 0.453 to 0.629
|
SECONDARY outcome
Timeframe: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entryOverall Survival (OS) was defined as the time from randomization to death from any cause. Patients who have not died would be censored at the date of last known alive. Median overall survival was estimated using Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entryOverall Survival (OS) was defined as the time from randomization to death from any cause. Patients who have not died would be censored at the date of last known alive. 3-year OS rate was defined as a proportion of patients who are alive after three years of follow-up time among all cases who have died within 3 years or alive after 3-year follow-up time. Kaplan-Meier method was used to estimate 3-year OS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: assessed at baseline and then every 12 weeks from start of treatment if patient is < 2 years from study entry (or < 2 years from crossover), then every 6 months until 5 years from study entryProgression-Free Survival (PFS) was defined as the time from randomization to disease progression or death (whichever occurs first). Cases without an event to date was censored at the date of last disease assessment documenting the patient was free of progression. Progression was evaluated based on international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Median PFS was estimated using Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: assessed at baseline and then every 12 weeks from start of treatment if patient is < 2 years from study entry (or < 2 years from crossover), then every 6 months until 5 years from study entryProgression-Free Survival (PFS) was defined as the time from randomization (arm A) or crossover (arm D) to disease progression or death (whichever occurs first). Cases without an event to date was censored at the date of last disease assessment documenting the patient was free of progression. Progression was evaluated based on international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Median PFS was estimated using Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: assessed at baseline and then every 12 weeks from start of treatment if patient is < 2 years from study entry (or < 2 years from crossover), then every 6 months until 5 years from study entryProgression-Free Survival (PFS) was defined as the time from randomization (arm B) or crossover (arm C) to disease progression or death (whichever occurs first). Cases without an event to date was censored at the date of last disease assessment documenting the patient was free of progression. Progression was evaluated based on international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Median PFS was estimated using Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: assessed at crossover and 12 weeks after treatment post-crossoverPercentage of crossover was defined as percentage of patients who are able to cross-over from one arm to the other and complete at least an initial course (12 weeks) of treatment after crossover without intervening symptomatic disease progression or treatment limiting toxicity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: assessed at baseline and 2 years after initiation of treatmentThe quality-adjusted time without symptoms of disease progression or toxicity of treatment (Q-TWiST) score was used to measure overall health. Differences between treatment groups in the mean Q-TWiST score were calculated. For each score, a 95% confidence interval (CI) and two-sided P-value for testing the null hypothesis of no difference between treatment groups were conducted using a Z-test (with normal approximation), with standard errors calculated by the bootstrap method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: assessed at baseline and then every 12 weeks from start of treatment if patient is < 2 years from study entry (or < 2 years from crossover), then every 6 months until 5 years from study entryResponse was assessed based on the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Response rate was defined as proportion of patients with complete response or partial response. Response rates were compared using the Mantel-Haenszel test (stratified by ECOG PS and LDH) test in arms A vs. B
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: assessed at baseline and then every 12 weeks from start of treatment if patient is < 2 years from study entry (or < 2 years from crossover), then every 6 months until 5 years from study entryResponse was assessed based on the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Response rate was defined as proportion of patients with complete response or partial response. Response rates were compared using Fisher exact test in arms A vs D.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: assessed at baseline and then every 12 weeks from start of treatment if patient is < 2 years from study entry (or < 2 years from crossover), then every 6 months until 5 years from study entryResponse was assessed based on the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Response rate was defined as proportion of patients with complete response or partial response. Response rates were compared using Fisher exact test in arms B vs C.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (Immunotherapy)
Serious events: 83 serious events
Other events: 124 other events
Deaths: 31 deaths
Arm B (BRAF Inhibitor Therapy)
Serious events: 75 serious events
Other events: 129 other events
Deaths: 49 deaths
Arm C (BRAF Inhibitor Therapy)
Serious events: 17 serious events
Other events: 29 other events
Deaths: 16 deaths
Arm D (Immunotherapy)
Serious events: 24 serious events
Other events: 44 other events
Deaths: 29 deaths
Serious adverse events
| Measure |
Arm A (Immunotherapy)
n=131 participants at risk
IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity.
IMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm C.
Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.
Biospecimen Collection: Undergo collection of blood samples
Computed Tomography: Undergo CT
Echocardiography Test: Undergo ECHO
Ipilimumab: Given IV
Multigated Acquisition Scan: Undergo MUGA scan
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm B (BRAF Inhibitor Therapy)
n=132 participants at risk
Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm D.
Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.
Biospecimen Collection: Undergo collection of blood samples
Computed Tomography: Undergo CT
Dabrafenib Mesylate: Given PO
Echocardiography Test: Undergo ECHO
Multigated Acquisition Scan: Undergo MUGA scan
Quality-of-Life Assessment: Ancillary studies
Trametinib Dimethyl Sulfoxide: Given PO
|
Arm C (BRAF Inhibitor Therapy)
n=29 participants at risk
Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.
Biospecimen Collection: Undergo collection of blood samples
Computed Tomography: Undergo CT
Dabrafenib Mesylate: Given PO
Echocardiography Test: Undergo ECHO
Multigated Acquisition Scan: Undergo MUGA scan
Quality-of-Life Assessment: Ancillary studies
Trametinib Dimethyl Sulfoxide: Given PO
|
Arm D (Immunotherapy)
n=52 participants at risk
IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity.
IMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.
Biospecimen Collection: Undergo collection of blood samples
Computed Tomography: Undergo CT
Echocardiography Test: Undergo ECHO
Ipilimumab: Given IV
Multigated Acquisition Scan: Undergo MUGA scan
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Blood and lymphatic system disorders
Anemia
|
3.1%
4/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.8%
5/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.8%
2/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.5%
2/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
1.5%
2/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.76%
1/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.5%
2/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Cardiac disorders
Myocarditis
|
1.5%
2/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Cardiac disorders
Pericardial effusion
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Cardiac disorders
Pericarditis
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Cardiac disorders
Cardiac disorders - Other
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.76%
1/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
General disorders
Edema limbs
|
1.5%
2/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
General disorders
Fatigue
|
8.4%
11/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.8%
9/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
5.8%
3/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
General disorders
Fever
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.8%
9/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
10.3%
3/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
General disorders
Flu like symptoms
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.5%
2/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
General disorders
Infusion related reaction
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
General disorders
Pain
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
General disorders
General disorders and administration site conditions - Other
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.3%
3/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.76%
1/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.8%
2/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.5%
2/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.6%
10/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
4.5%
6/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
10.3%
3/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Endocrine disorders
Adrenal insufficiency
|
1.5%
2/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Endocrine disorders
Endocrine disorders - Other
|
3.8%
5/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
5.8%
3/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
5/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Gastrointestinal disorders
Colitis
|
6.1%
8/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Gastrointestinal disorders
Constipation
|
1.5%
2/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Gastrointestinal disorders
Diarrhea
|
18.3%
24/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.5%
2/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.8%
2/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Gastrointestinal disorders
Enterocolitis
|
2.3%
3/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Gastrointestinal disorders
Ileus
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Gastrointestinal disorders
Nausea
|
6.9%
9/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.8%
2/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.76%
1/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
5/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
2.3%
3/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Immune system disorders
Autoimmune disorder
|
2.3%
3/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Immune system disorders
Cytokine release syndrome
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Infections and infestations
Encephalitis infection
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.76%
1/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Infections and infestations
Enterocolitis infectious
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Infections and infestations
Gallbladder infection
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.76%
1/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Infections and infestations
Lung infection
|
1.5%
2/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.76%
1/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.8%
2/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Infections and infestations
Meningitis
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Infections and infestations
Sepsis
|
2.3%
3/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.5%
2/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Infections and infestations
Skin infection
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.5%
2/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Infections and infestations
Urinary tract infection
|
2.3%
3/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.5%
2/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Injury, poisoning and procedural complications
Fall
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
Alanine aminotransferase increased
|
6.1%
8/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.5%
2/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.8%
2/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
Aspartate aminotransferase increased
|
6.1%
8/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.0%
4/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.8%
2/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
Blood bilirubin increased
|
2.3%
3/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.76%
1/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
CPK increased
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.5%
2/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
Creatinine increased
|
1.5%
2/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.5%
2/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.1%
8/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
GGT increased
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
Lipase increased
|
13.7%
18/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.8%
9/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
5.8%
3/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
Lymphocyte count decreased
|
1.5%
2/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
2.3%
3/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.9%
2/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
5.8%
3/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.1%
8/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
Serum amylase increased
|
6.1%
8/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.76%
1/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
Weight loss
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
White blood cell decreased
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.0%
4/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
Investigations - Other
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.76%
1/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Metabolism and nutrition disorders
Anorexia
|
3.1%
4/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.76%
1/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
5/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
2.3%
3/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.1%
4/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
2.3%
3/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.8%
5/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.5%
2/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
2.3%
3/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.6%
6/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.8%
9/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
10.3%
3/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
7/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.76%
1/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.5%
2/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.76%
1/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.76%
1/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.3%
3/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.5%
2/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
1.5%
2/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.5%
2/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.5%
2/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Nervous system disorders
Headache
|
2.3%
3/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.76%
1/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Nervous system disorders
Hypersomnia
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Nervous system disorders
Syncope
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
2.3%
3/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Nervous system disorders
Tremor
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Nervous system disorders
Nervous system disorders - Other
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.8%
2/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.5%
2/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Eye disorders
Blurred vision
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.76%
1/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Eye disorders
Extraocular muscle paresis
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.76%
1/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Eye disorders
Uveitis
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.5%
2/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Psychiatric disorders
Confusion
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.76%
1/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.76%
1/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.76%
1/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.5%
2/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.76%
1/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.1%
4/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.76%
1/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Vascular disorders
Hypertension
|
1.5%
2/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
2.3%
3/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Vascular disorders
Hypotension
|
4.6%
6/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.0%
4/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.5%
2/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
Other adverse events
| Measure |
Arm A (Immunotherapy)
n=131 participants at risk
IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity.
IMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm C.
Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.
Biospecimen Collection: Undergo collection of blood samples
Computed Tomography: Undergo CT
Echocardiography Test: Undergo ECHO
Ipilimumab: Given IV
Multigated Acquisition Scan: Undergo MUGA scan
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Arm B (BRAF Inhibitor Therapy)
n=132 participants at risk
Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm D.
Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.
Biospecimen Collection: Undergo collection of blood samples
Computed Tomography: Undergo CT
Dabrafenib Mesylate: Given PO
Echocardiography Test: Undergo ECHO
Multigated Acquisition Scan: Undergo MUGA scan
Quality-of-Life Assessment: Ancillary studies
Trametinib Dimethyl Sulfoxide: Given PO
|
Arm C (BRAF Inhibitor Therapy)
n=29 participants at risk
Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.
Biospecimen Collection: Undergo collection of blood samples
Computed Tomography: Undergo CT
Dabrafenib Mesylate: Given PO
Echocardiography Test: Undergo ECHO
Multigated Acquisition Scan: Undergo MUGA scan
Quality-of-Life Assessment: Ancillary studies
Trametinib Dimethyl Sulfoxide: Given PO
|
Arm D (Immunotherapy)
n=52 participants at risk
IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity.
IMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.
Biospecimen Collection: Undergo collection of blood samples
Computed Tomography: Undergo CT
Echocardiography Test: Undergo ECHO
Ipilimumab: Given IV
Multigated Acquisition Scan: Undergo MUGA scan
Nivolumab: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
22.9%
30/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
34.8%
46/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
27.6%
8/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
19.2%
10/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
5.3%
7/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
5.3%
7/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
7.7%
4/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
General disorders
Fever
|
21.4%
28/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
54.5%
72/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
55.2%
16/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
21.2%
11/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Cardiac disorders
Sinus tachycardia
|
6.9%
9/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.5%
2/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
General disorders
Chills
|
6.9%
9/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
35.6%
47/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
31.0%
9/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.8%
2/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
General disorders
Edema limbs
|
10.7%
14/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
17.4%
23/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
13.8%
4/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
5.8%
3/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
General disorders
Fatigue
|
61.8%
81/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
69.7%
92/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
62.1%
18/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
61.5%
32/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
General disorders
Flu like symptoms
|
4.6%
6/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
8.3%
11/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.9%
2/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.8%
2/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
General disorders
Malaise
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
5.8%
3/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
General disorders
Pain
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.9%
2/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.8%
2/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
General disorders
General disorders and administration site conditions - Other
|
1.5%
2/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
5.3%
7/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.6%
6/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.1%
8/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
5.8%
3/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.6%
6/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
8.3%
11/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
5.8%
3/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.8%
9/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
40.5%
53/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
22.7%
30/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
27.6%
8/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
38.5%
20/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
10.3%
3/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
53.4%
70/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
33.3%
44/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
24.1%
7/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
38.5%
20/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
6.9%
9/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
15.3%
20/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
8.3%
11/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
24.1%
7/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
13.5%
7/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Endocrine disorders
Adrenal insufficiency
|
13.0%
17/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
13.5%
7/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Endocrine disorders
Hyperthyroidism
|
16.0%
21/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
11.5%
6/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Endocrine disorders
Hypothyroidism
|
31.3%
41/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.0%
4/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
10.3%
3/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
36.5%
19/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Endocrine disorders
Endocrine disorders - Other
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
7.7%
4/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Gastrointestinal disorders
Abdominal pain
|
19.1%
25/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
10.6%
14/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
17.2%
5/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
5.8%
3/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Gastrointestinal disorders
Constipation
|
6.1%
8/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
12.1%
16/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Gastrointestinal disorders
Diarrhea
|
41.2%
54/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
38.6%
51/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
34.5%
10/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
30.8%
16/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Gastrointestinal disorders
Dry mouth
|
7.6%
10/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
5.3%
7/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
7.7%
4/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
5.8%
3/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Gastrointestinal disorders
Mucositis oral
|
5.3%
7/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.1%
8/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Gastrointestinal disorders
Nausea
|
45.8%
60/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
43.2%
57/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
37.9%
11/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
19.2%
10/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Gastrointestinal disorders
Vomiting
|
19.1%
25/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
28.0%
37/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
10.3%
3/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
13.5%
7/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
Alanine aminotransferase increased
|
26.7%
35/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
32.6%
43/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
17.2%
5/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
28.8%
15/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
Alkaline phosphatase increased
|
9.9%
13/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
30.3%
40/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
17.2%
5/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
13.5%
7/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
Aspartate aminotransferase increased
|
26.7%
35/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
34.8%
46/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
20.7%
6/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
19.2%
10/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
Blood bilirubin increased
|
8.4%
11/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.1%
8/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
CPK increased
|
5.3%
7/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
19.7%
26/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.9%
2/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.8%
2/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
Creatinine increased
|
8.4%
11/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
15.2%
20/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
17.2%
5/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
7.7%
4/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
9.1%
12/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
10.3%
3/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
Lipase increased
|
9.9%
13/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
21.2%
28/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
20.7%
6/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
9.6%
5/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
Lymphocyte count decreased
|
8.4%
11/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
18.9%
25/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
10.3%
3/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
9.6%
5/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
Neutrophil count decreased
|
2.3%
3/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
15.9%
21/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
13.8%
4/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
Platelet count decreased
|
5.3%
7/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
15.9%
21/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
Serum amylase increased
|
6.9%
9/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
12.9%
17/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.9%
2/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
Weight loss
|
14.5%
19/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
12.1%
16/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.9%
2/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
13.5%
7/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
White blood cell decreased
|
2.3%
3/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
24.2%
32/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
17.2%
5/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
5.8%
3/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Investigations
Investigations - Other
|
7.6%
10/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
11.4%
15/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.9%
2/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
9.6%
5/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Metabolism and nutrition disorders
Anorexia
|
32.1%
42/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
29.5%
39/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
24.1%
7/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
26.9%
14/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
5/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.1%
8/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.9%
2/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.5%
15/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
14.4%
19/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.9%
2/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
7.7%
4/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
6.9%
9/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
2.3%
3/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
10.3%
3/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
5.8%
3/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.7%
14/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
25.0%
33/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
24.1%
7/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
15.4%
8/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.6%
10/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.1%
8/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.9%
2/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.1%
8/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
9.1%
12/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.9%
2/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
5.8%
3/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.2%
12/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
18.9%
25/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
17.2%
5/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
7.7%
4/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.0%
34/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
24.2%
32/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
31.0%
9/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
25.0%
13/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.1%
8/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
7.6%
10/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
10.3%
3/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
5.8%
3/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.8%
22/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
15.2%
20/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
13.8%
4/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
11.5%
6/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Nervous system disorders
Dizziness
|
7.6%
10/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
7.6%
10/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
13.8%
4/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
5.8%
3/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Nervous system disorders
Dysgeusia
|
4.6%
6/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
10.6%
14/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.9%
2/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Nervous system disorders
Headache
|
24.4%
32/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
28.8%
38/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
24.1%
7/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
17.3%
9/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.9%
2/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.3%
7/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
4.5%
6/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Eye disorders
Blurred vision
|
8.4%
11/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
15.9%
21/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
24.1%
7/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
7.7%
4/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Eye disorders
Dry eye
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
5.8%
3/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Eye disorders
Uveitis
|
6.9%
9/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.1%
8/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
10.3%
3/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Eye disorders
Eye disorders - Other
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.9%
2/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
7.7%
4/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Psychiatric disorders
Insomnia
|
6.1%
8/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.0%
4/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.9%
2/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.2%
12/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
23.5%
31/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
10.3%
3/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
7.7%
4/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.0%
17/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
18.9%
25/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
13.8%
4/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
7.7%
4/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.9%
2/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
10.3%
3/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
1.9%
1/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Vascular disorders
Flushing
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
10.3%
3/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Vascular disorders
Hot flashes
|
3.8%
5/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.1%
8/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Vascular disorders
Hypertension
|
5.3%
7/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
13.6%
18/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
6.9%
2/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
5.8%
3/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
|
Vascular disorders
Hypotension
|
0.00%
0/131 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
0.00%
0/132 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
3.4%
1/29 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
5.8%
3/52 • Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60