Trial Outcomes & Findings for Nivolumab, Ifosfamide, Carboplatin, and Etoposide as Second-Line Therapy in Treating Patients With Refractory or Relapsed HL (NCT NCT03016871)
NCT ID: NCT03016871
Last Updated: 2025-10-17
Results Overview
Toxicities were assessed and reported using the Bearman (non-hematologic) and National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 scales. Unacceptable toxicity in a given patient is defined as any non-hematologic or hematological grade 3/4 toxicity that did not resolve to a grade 1/2 within 14 days per NCI CTCAE v4.03 toxicity criteria and was considered at least possibly related to nivolumab and/or ICE, or any other regimen-related cause of death.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
78 participants
Primary outcome timeframe
From initial treatment to the end of the study, up to 77 months.
Results posted on
2025-10-17
Participant Flow
Participant milestones
| Measure |
Cohort A (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 14 days for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with CR or PR receive nivolumab for an additional 6 weeks. Patients with only SD after 6-week nivolumab treatment receive nivolumab for an additional 6 weeks or receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2 every 21 days for 6 weeks per physician/investigator's discretion. Patients with PD after 6-week nivolumab treatment or patients with PR, SD, or PD after 12-week nivolumab treatment receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
Cohort B (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
Patients receive nivolumab IV over 30 minutes on cycle 1 (cycle 1 is 14 days), day 1 in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
35
|
|
Overall Study
COMPLETED
|
43
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nivolumab, Ifosfamide, Carboplatin, and Etoposide as Second-Line Therapy in Treating Patients With Refractory or Relapsed HL
Baseline characteristics by cohort
| Measure |
Cohort A (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
n=43 Participants
Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 14 days for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with CR or PR receive nivolumab for an additional 6 weeks. Patients with only SD after 6-week nivolumab treatment receive nivolumab for an additional 6 weeks or receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2 every 21 days for 6 weeks per physician/investigator's discretion. Patients with PD after 6-week nivolumab treatment or patients with PR, SD, or PD after 12-week nivolumab treatment receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
Cohort B (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
n=35 Participants
Patients receive nivolumab IV over 30 minutes on cycle 1 (cycle 1 is 14 days), day 1 in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35 years
n=99 Participants
|
30 years
n=107 Participants
|
31.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=99 Participants
|
35 participants
n=107 Participants
|
78 participants
n=206 Participants
|
|
Bulky Disease at Baseline
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
B Symptoms at Baseline
|
15 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Extranodal Disease at Baseline
|
16 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From the initial treatment to the end of the treatment, up to 6 months.Population: 1 participant in Cohort A and 3 participants in Cohort B were not evaluable for treatment response.
Complete response rates were calculated as the percent of evaluable patients that have confirmed complete response by radiographic response including computed tomography and/or positron emission tomography scans; 95% Clopper Pearson confidence limits were calculated for this estimate.
Outcome measures
| Measure |
Cohort A (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
n=42 Participants
Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 14 days for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with CR or PR receive nivolumab for an additional 6 weeks. Patients with only SD after 6-week nivolumab treatment receive nivolumab for an additional 6 weeks or receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2 every 21 days for 6 weeks per physician/investigator's discretion. Patients with PD after 6-week nivolumab treatment or patients with PR, SD, or PD after 12-week nivolumab treatment receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
Cohort B (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
n=32 Participants
Patients receive nivolumab IV over 30 minutes on cycle 1 (cycle 1 is 14 days), day 1 in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
|---|---|---|
|
Complete Response Rate by Lugano Classification
|
71 percentage of participants
Interval 55.0 to 84.0
|
88 percentage of participants
Interval 71.0 to 96.0
|
PRIMARY outcome
Timeframe: From initial treatment to the end of the study, up to 77 months.Toxicities were assessed and reported using the Bearman (non-hematologic) and National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 scales. Unacceptable toxicity in a given patient is defined as any non-hematologic or hematological grade 3/4 toxicity that did not resolve to a grade 1/2 within 14 days per NCI CTCAE v4.03 toxicity criteria and was considered at least possibly related to nivolumab and/or ICE, or any other regimen-related cause of death.
Outcome measures
| Measure |
Cohort A (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
n=43 Participants
Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 14 days for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with CR or PR receive nivolumab for an additional 6 weeks. Patients with only SD after 6-week nivolumab treatment receive nivolumab for an additional 6 weeks or receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2 every 21 days for 6 weeks per physician/investigator's discretion. Patients with PD after 6-week nivolumab treatment or patients with PR, SD, or PD after 12-week nivolumab treatment receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
Cohort B (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
n=35 Participants
Patients receive nivolumab IV over 30 minutes on cycle 1 (cycle 1 is 14 days), day 1 in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
|---|---|---|
|
Number of Participants With Unacceptable Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the initial treatment to the end of the treatment, up to 6 months.Population: 1 participant in Cohort A and 3 participants in Cohort B were not evaluable for treatment response.
Overall response rate was calculated as the percent of evaluable patients that have confirmed complete response or partial remission by radiographic response including computed tomography and/or positron emission tomography scans; 95% Clopper Pearson confidence limits were calculated for this estimate.
Outcome measures
| Measure |
Cohort A (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
n=42 Participants
Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 14 days for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with CR or PR receive nivolumab for an additional 6 weeks. Patients with only SD after 6-week nivolumab treatment receive nivolumab for an additional 6 weeks or receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2 every 21 days for 6 weeks per physician/investigator's discretion. Patients with PD after 6-week nivolumab treatment or patients with PR, SD, or PD after 12-week nivolumab treatment receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
Cohort B (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
n=32 Participants
Patients receive nivolumab IV over 30 minutes on cycle 1 (cycle 1 is 14 days), day 1 in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
|---|---|---|
|
Overall Response Rate
|
81 percentage of participants
Interval 66.0 to 91.0
|
100 percentage of participants
Interval 89.0 to 100.0
|
SECONDARY outcome
Timeframe: 2 years from start of treatmentOverall survival (OS) is defined as the duration of time from start of study treatment to time of death (due to any cause). OS rate was estimated using the product-limit method of Kaplan and Meier. The event is death.
Outcome measures
| Measure |
Cohort A (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
n=43 Participants
Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 14 days for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with CR or PR receive nivolumab for an additional 6 weeks. Patients with only SD after 6-week nivolumab treatment receive nivolumab for an additional 6 weeks or receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2 every 21 days for 6 weeks per physician/investigator's discretion. Patients with PD after 6-week nivolumab treatment or patients with PR, SD, or PD after 12-week nivolumab treatment receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
Cohort B (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
n=35 Participants
Patients receive nivolumab IV over 30 minutes on cycle 1 (cycle 1 is 14 days), day 1 in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
|---|---|---|
|
Two-Year Overall Survival (OS) Rate
|
95 percentage of participants
Interval 82.0 to 99.0
|
100 percentage of participants
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: 2 years from start of treatmentProgression-free survival is defined as the duration of time from start of study treatment to time of progression or death, whichever occurs first. PFS rate was estimated using the product-limit method of Kaplan and Meier. The event is progression/relapse or death.
Outcome measures
| Measure |
Cohort A (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
n=43 Participants
Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 14 days for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with CR or PR receive nivolumab for an additional 6 weeks. Patients with only SD after 6-week nivolumab treatment receive nivolumab for an additional 6 weeks or receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2 every 21 days for 6 weeks per physician/investigator's discretion. Patients with PD after 6-week nivolumab treatment or patients with PR, SD, or PD after 12-week nivolumab treatment receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
Cohort B (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
n=35 Participants
Patients receive nivolumab IV over 30 minutes on cycle 1 (cycle 1 is 14 days), day 1 in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
|---|---|---|
|
Two-Year Progression-Free Survival (PFS) Rate
|
72 percentage of participants
Interval 56.0 to 83.0
|
94 percentage of participants
Interval 77.0 to 98.0
|
SECONDARY outcome
Timeframe: From start of transplant to time of progression, death (due to any cause), or last contact, whichever comes first, assessed 2 years post-transplant, up to 3 years.Progression-free survival (PFS) is defined as the duration of time from start of transplant to time of progression or death, whichever occurs first. PFS rate was estimated using the product-limit method of Kaplan and Meier. The event is post-transplant progression/relapse or death.
Outcome measures
| Measure |
Cohort A (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
n=33 Participants
Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 14 days for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with CR or PR receive nivolumab for an additional 6 weeks. Patients with only SD after 6-week nivolumab treatment receive nivolumab for an additional 6 weeks or receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2 every 21 days for 6 weeks per physician/investigator's discretion. Patients with PD after 6-week nivolumab treatment or patients with PR, SD, or PD after 12-week nivolumab treatment receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
Cohort B (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
n=32 Participants
Patients receive nivolumab IV over 30 minutes on cycle 1 (cycle 1 is 14 days), day 1 in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
|---|---|---|
|
Two-Year Progression-Free Survival Rate (Post Autologous Transplant)
|
94 percentage of participants
Interval 77.0 to 98.0
|
97 percentage of participants
Interval 80.0 to 100.0
|
SECONDARY outcome
Timeframe: 2 years from start of treatmentThe cumulative incidence of relapse/progression was calculated as competing risks using the method of Gooley et al. The event is relapse/progression. Deaths without relapse/progression are considered a competing risk.
Outcome measures
| Measure |
Cohort A (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
n=43 Participants
Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 14 days for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with CR or PR receive nivolumab for an additional 6 weeks. Patients with only SD after 6-week nivolumab treatment receive nivolumab for an additional 6 weeks or receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2 every 21 days for 6 weeks per physician/investigator's discretion. Patients with PD after 6-week nivolumab treatment or patients with PR, SD, or PD after 12-week nivolumab treatment receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
Cohort B (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
n=35 Participants
Patients receive nivolumab IV over 30 minutes on cycle 1 (cycle 1 is 14 days), day 1 in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
|---|---|---|
|
Cumulative Incidence of Relapse/Progression at 2 Years
|
9 percentage of participants
Interval 4.0 to 24.0
|
6 percentage of participants
Interval 2.0 to 24.0
|
SECONDARY outcome
Timeframe: 2 years from start of treatmentThe cumulative incidence of non-relapse mortality was calculated as competing risks using the method of Gooley et al. NRM is defined as death occurring in a patient from causes other than relapse or progression. Deaths from relapse/progression are considered a competing risk.
Outcome measures
| Measure |
Cohort A (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
n=43 Participants
Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 14 days for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with CR or PR receive nivolumab for an additional 6 weeks. Patients with only SD after 6-week nivolumab treatment receive nivolumab for an additional 6 weeks or receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2 every 21 days for 6 weeks per physician/investigator's discretion. Patients with PD after 6-week nivolumab treatment or patients with PR, SD, or PD after 12-week nivolumab treatment receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
Cohort B (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
n=35 Participants
Patients receive nivolumab IV over 30 minutes on cycle 1 (cycle 1 is 14 days), day 1 in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
|---|---|---|
|
Non-relapse Mortality (NRM) at 2 Years
|
2 percentage of participants
Interval 0.3 to 16.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
Adverse Events
Cohort A (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
Serious events: 5 serious events
Other events: 42 other events
Deaths: 2 deaths
Cohort B (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
Serious events: 3 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
n=43 participants at risk
Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 14 days for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with CR or PR receive nivolumab for an additional 6 weeks. Patients with only SD after 6-week nivolumab treatment receive nivolumab for an additional 6 weeks or receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2 every 21 days for 6 weeks per physician/investigator's discretion. Patients with PD after 6-week nivolumab treatment or patients with PR, SD, or PD after 12-week nivolumab treatment receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
Cohort B (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
n=35 participants at risk
Patients receive nivolumab IV over 30 minutes on cycle 1 (cycle 1 is 14 days), day 1 in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Endocrine disorders
Adrenal insufficiency
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Endocrine disorders
Thyroiditis
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Gastrointestinal disorders
Colitis
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
General disorders
Fever
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
5.7%
2/35 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Infections and infestations
Sepsis
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Nervous system disorders
Altered Mental Status
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Pregnancy, puerperium and perinatal conditions
Unintended pregnancy
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration, Intubation
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
Other adverse events
| Measure |
Cohort A (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
n=43 participants at risk
Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 14 days for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with CR or PR receive nivolumab for an additional 6 weeks. Patients with only SD after 6-week nivolumab treatment receive nivolumab for an additional 6 weeks or receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2 every 21 days for 6 weeks per physician/investigator's discretion. Patients with PD after 6-week nivolumab treatment or patients with PR, SD, or PD after 12-week nivolumab treatment receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
Cohort B (Nivolumab, Etoposide, Ifosfamide, Carboplatin)
n=35 participants at risk
Patients receive nivolumab IV over 30 minutes on cycle 1 (cycle 1 is 14 days), day 1 in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Etoposide: Given IV
Ifosfamide: Given IV
Laboratory Biomarker Analysis: Correlative studies
Nivolumab: Given IV
|
|---|---|---|
|
Metabolism and nutrition disorders
HYPERURICEMIA
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
9.3%
4/43 • Number of events 7 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
9.3%
4/43 • Number of events 4 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
5.7%
2/35 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
16.3%
7/43 • Number of events 16 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
8.6%
3/35 • Number of events 4 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
16.3%
7/43 • Number of events 12 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
11.4%
4/35 • Number of events 5 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
8.6%
3/35 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
25.6%
11/43 • Number of events 13 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
11.4%
4/35 • Number of events 7 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
14.0%
6/43 • Number of events 10 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
5.7%
2/35 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Metabolism and nutrition disorders
OBESITY
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
8.6%
3/35 • Number of events 4 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Metabolism and nutrition disorders
TUMOR LYSIS SYNDROME
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
16.3%
7/43 • Number of events 10 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
11.4%
4/35 • Number of events 5 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
2.3%
1/43 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
20.9%
9/43 • Number of events 14 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
14.3%
5/35 • Number of events 5 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Musculoskeletal and connective tissue disorders
BILATERAL KNEE PAIN
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Musculoskeletal and connective tissue disorders
CRAMPING
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS LOWER LIMB
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
4.7%
2/43 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
5.7%
2/35 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
5.7%
2/35 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
5.7%
2/35 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PERIRECTAL LUMP/ BULGE
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Nervous system disorders
AMNESIA
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Nervous system disorders
DIZZINESS
|
7.0%
3/43 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
14.3%
5/35 • Number of events 5 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Nervous system disorders
HEADACHE
|
20.9%
9/43 • Number of events 9 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
20.0%
7/35 • Number of events 7 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Nervous system disorders
HYPERSOMNIA
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Nervous system disorders
LETHARGY
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Nervous system disorders
NEUROPATHIC PAIN
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Nervous system disorders
PARESTHESIA
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
2.3%
1/43 • Number of events 4 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
9.3%
4/43 • Number of events 4 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
14.3%
5/35 • Number of events 5 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Nervous system disorders
SOMNOLENCE
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Nervous system disorders
SYNCOPE
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Psychiatric disorders
AGITATION
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Psychiatric disorders
ANXIETY
|
16.3%
7/43 • Number of events 9 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
17.1%
6/35 • Number of events 6 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Psychiatric disorders
DEPRESSION
|
4.7%
2/43 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Psychiatric disorders
INSOMNIA
|
9.3%
4/43 • Number of events 4 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
14.3%
5/35 • Number of events 6 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Psychiatric disorders
RESTLESSNESS
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Renal and urinary disorders
BACTERIA 2+ ON UA
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Renal and urinary disorders
BLADDER PRESSURE
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
5.7%
2/35 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Renal and urinary disorders
CHRONIC KIDNEY DISEASE
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Renal and urinary disorders
DYSURIA
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
25.7%
9/35 • Number of events 11 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Renal and urinary disorders
HEMATURIA
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
17.1%
6/35 • Number of events 6 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Renal and urinary disorders
HEMORRHAGIC CYSTITIS
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
5.7%
2/35 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Renal and urinary disorders
PROTEINURIA
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
14.3%
5/35 • Number of events 5 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
2.3%
1/43 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
8.6%
3/35 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Renal and urinary disorders
URINARY TRACT PAIN
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
5.7%
2/35 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Reproductive system and breast disorders
BREAST PAIN
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
2.3%
1/43 • Number of events 4 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Reproductive system and breast disorders
VAGINAL PAIN
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS
|
9.3%
4/43 • Number of events 8 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
16.3%
7/43 • Number of events 8 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
8.6%
3/35 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
7.0%
3/43 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
20.0%
7/35 • Number of events 8 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
4.7%
2/43 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
5.7%
2/35 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Respiratory, thoracic and mediastinal disorders
HOARSENESS
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
7.0%
3/43 • Number of events 4 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
5.7%
2/35 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Blood and lymphatic system disorders
ANEMIA
|
27.9%
12/43 • Number of events 23 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
77.1%
27/35 • Number of events 42 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
5.7%
2/35 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
8.6%
3/35 • Number of events 5 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
16.3%
7/43 • Number of events 7 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
54.3%
19/35 • Number of events 30 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Ear and labyrinth disorders
EAR PAIN
|
2.3%
1/43 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
4.7%
2/43 • Number of events 5 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
8.6%
3/35 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Eye disorders
BLURRED VISION
|
7.0%
3/43 • Number of events 5 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
5.7%
2/35 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Eye disorders
CONJUNCTIVITIS
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Eye disorders
DRY EYE
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Eye disorders
SWELLING EYE
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Eye disorders
VISUAL DISTURBANCE
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Eye disorders
VITREOUS HEMORRHAGE
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Eye disorders
WATERING EYES
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
14.0%
6/43 • Number of events 8 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
11.4%
4/35 • Number of events 5 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Gastrointestinal disorders
BLOATING
|
4.7%
2/43 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Gastrointestinal disorders
BLOOD IN STOOL
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Gastrointestinal disorders
BLOODY STOOL
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Gastrointestinal disorders
CONSTIPATION
|
18.6%
8/43 • Number of events 10 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
40.0%
14/35 • Number of events 15 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Gastrointestinal disorders
DIARRHEA
|
14.0%
6/43 • Number of events 10 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
11.4%
4/35 • Number of events 4 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
4.7%
2/43 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Gastrointestinal disorders
FLATULENCE
|
4.7%
2/43 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Gastrointestinal disorders
GERD SYMPTOMS
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Gastrointestinal disorders
HEARTBURN
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Gastrointestinal disorders
LIP PAIN
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
7.0%
3/43 • Number of events 6 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
5.7%
2/35 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Gastrointestinal disorders
NAUSEA
|
34.9%
15/43 • Number of events 22 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
74.3%
26/35 • Number of events 41 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Gastrointestinal disorders
STOMACH DISCOMFORT
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Gastrointestinal disorders
TOOTHACHE
|
4.7%
2/43 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Gastrointestinal disorders
VOMITING
|
18.6%
8/43 • Number of events 9 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
45.7%
16/35 • Number of events 21 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
General disorders
CHILLS
|
11.6%
5/43 • Number of events 6 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
11.4%
4/35 • Number of events 4 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
General disorders
EDEMA FACE
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
5.7%
2/35 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
General disorders
EDEMA HANDS
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
General disorders
EDEMA LIMBS
|
4.7%
2/43 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
5.7%
2/35 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
General disorders
FATIGUE
|
44.2%
19/43 • Number of events 33 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
68.6%
24/35 • Number of events 34 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
General disorders
FEET
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
General disorders
FEVER
|
18.6%
8/43 • Number of events 12 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
8.6%
3/35 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
General disorders
GLUCOSURIA
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
General disorders
INFUSION RELATED REACTION
|
7.0%
3/43 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
General disorders
INJECTION SITE REACTION
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
5.7%
2/35 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
General disorders
MALAISE
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
General disorders
NECK EDEMA
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
4.7%
2/43 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
8.6%
3/35 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
General disorders
PAIN
|
7.0%
3/43 • Number of events 5 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
General disorders
RUNNY NOSE
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
General disorders
SCALP SENSITIVITY
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Immune system disorders
ALLERGIC REACTION
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
5.7%
2/35 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Infections and infestations
COVID-19
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
5.7%
2/35 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Infections and infestations
PAPULOPUSTULAR RASH
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Infections and infestations
PARONYCHIA
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Infections and infestations
PERIANAL FOLLICULITS
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Infections and infestations
PICC LINE ISSUES
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Infections and infestations
RASH PUSTULAR
|
2.3%
1/43 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Infections and infestations
SEPSIS
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Infections and infestations
TOOTH INFECTION
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
7.0%
3/43 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Infections and infestations
VAGINAL INFECTION
|
7.0%
3/43 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Infections and infestations
YEAST INFECTION
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
|
7.0%
3/43 • Number of events 9 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
14.3%
5/35 • Number of events 6 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
25.6%
11/43 • Number of events 17 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
22.9%
8/35 • Number of events 8 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
11.6%
5/43 • Number of events 10 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
8.6%
3/35 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
16.3%
7/43 • Number of events 10 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
11.4%
4/35 • Number of events 4 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
9.3%
4/43 • Number of events 5 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Investigations
CREATININE INCREASED
|
7.0%
3/43 • Number of events 4 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Investigations
EOSINOPHILIA
|
2.3%
1/43 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Investigations
HEMOGLOBIN INCREASED
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
9.3%
4/43 • Number of events 7 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
22.9%
8/35 • Number of events 13 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
20.9%
9/43 • Number of events 14 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
34.3%
12/35 • Number of events 15 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Investigations
PLATELET COUNT DECREASED
|
18.6%
8/43 • Number of events 23 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
31.4%
11/35 • Number of events 20 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Investigations
WEIGHT GAIN
|
4.7%
2/43 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
14.3%
5/35 • Number of events 9 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Investigations
WEIGHT LOSS
|
7.0%
3/43 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
5.7%
2/35 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
20.9%
9/43 • Number of events 17 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
31.4%
11/35 • Number of events 15 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Metabolism and nutrition disorders
ACIDOSIS
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Metabolism and nutrition disorders
ALKALOSIS
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
4.7%
2/43 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
25.7%
9/35 • Number of events 9 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
2.3%
1/43 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
14.0%
6/43 • Number of events 8 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
2.3%
1/43 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Respiratory, thoracic and mediastinal disorders
POSTNASAL DRIP
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
7.0%
3/43 • Number of events 7 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
8.6%
3/35 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Skin and subcutaneous tissue disorders
BULLOUS DERMATITIS
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Skin and subcutaneous tissue disorders
CYSTIC LESION
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
4.7%
2/43 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Skin and subcutaneous tissue disorders
HYPOHIDROSIS
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Skin and subcutaneous tissue disorders
PALLOR
|
2.3%
1/43 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
23.3%
10/43 • Number of events 10 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
17.1%
6/35 • Number of events 8 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Skin and subcutaneous tissue disorders
RASH ACNEIFORM
|
4.7%
2/43 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
8.6%
3/35 • Number of events 3 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
30.2%
13/43 • Number of events 16 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
8.6%
3/35 • Number of events 4 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Skin and subcutaneous tissue disorders
WART
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/43 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Vascular disorders
FLUSHING
|
2.3%
1/43 • Number of events 2 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
2.9%
1/35 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Vascular disorders
HOT FLASHES
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
8.6%
3/35 • Number of events 4 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Vascular disorders
HYPERTENSION
|
27.9%
12/43 • Number of events 25 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
57.1%
20/35 • Number of events 40 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
|
Vascular disorders
HYPOTENSION
|
2.3%
1/43 • Number of events 1 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
0.00%
0/35 • Adverse events and all-cause mortality were monitored/assessed from initial treatment to the end of protocol follow-up, up to 77 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place