Trial Outcomes & Findings for Ofatumumab and Bendamustine Hydrochloride With or Without Bortezomib in Treating Patients With Untreated Follicular Non-Hodgkin Lymphoma (NCT NCT01286272)
NCT ID: NCT01286272
Last Updated: 2025-11-10
Results Overview
A complete response was defined using International Harmonization Project Response Criteria as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. If the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. The complete response (CR) rate was calculated in newly diagnosed untreated follicular lymphoma patients receiving 6 cycles of ofatumumab-bendamustine (ARM A) and 6 cycles of ofatumumab, bortezomib, and bendamustine (ARM B). The complete response rate was calculated as the number of patients with a complete response divided by the number of patients eligible for evaluation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
135 participants
Primary outcome timeframe
From date of randomization until patient stops treatment for any reason, up to 484 days post-randomization
Results posted on
2025-11-10
Participant Flow
One hundred thirty five patients registered to this trial. However, 3 patients cancelled prior to receiving any study treatment and were excluded from all analyses.
Participant milestones
| Measure |
Arm A (Ofatumumab, Bendamustine Hydrochloride)
INDUCTION: Patients receive:\> 300 mg ofatumumab IV over 2-8 hours on day 1, cycle1 and 1000 mg ofatumumab IV on day 1, cycle 2-6 and 90 mg/m2 bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy. \>
\> MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive 1000 mg ofatumumab IV over 2-8 hours on day 1. Treatment repeats every 56 days for up to 4 courses.
|
Arm B (Ofatumumab, Bendamustine Hydrochloride, Bortezomib)
INDUCTION: Patients receive 300 mg ofatumumab IV over 2-8 hours on day 1, cycle1 and 1000 mg ofatumumab IV on day 1, cycle 2-6 and 90 mg/m2 bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, and 1.6 mg/m2 bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy. \>
\> MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive 1000 mg ofatumumab IV over 2-8 hours on day 1 and 1.6 mg/m2 bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 56 days for up to 4 courses.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
65
|
|
Overall Study
COMPLETED
|
66
|
62
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Arm A (Ofatumumab, Bendamustine Hydrochloride)
INDUCTION: Patients receive:\> 300 mg ofatumumab IV over 2-8 hours on day 1, cycle1 and 1000 mg ofatumumab IV on day 1, cycle 2-6 and 90 mg/m2 bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy. \>
\> MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive 1000 mg ofatumumab IV over 2-8 hours on day 1. Treatment repeats every 56 days for up to 4 courses.
|
Arm B (Ofatumumab, Bendamustine Hydrochloride, Bortezomib)
INDUCTION: Patients receive 300 mg ofatumumab IV over 2-8 hours on day 1, cycle1 and 1000 mg ofatumumab IV on day 1, cycle 2-6 and 90 mg/m2 bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, and 1.6 mg/m2 bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy. \>
\> MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive 1000 mg ofatumumab IV over 2-8 hours on day 1 and 1.6 mg/m2 bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 56 days for up to 4 courses.
|
|---|---|---|
|
Overall Study
Ineligible after beginning treatment
|
1
|
3
|
Baseline Characteristics
Ofatumumab and Bendamustine Hydrochloride With or Without Bortezomib in Treating Patients With Untreated Follicular Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Arm A (Ofatumumab, Bendamustine Hydrochloride)
n=66 Participants
INDUCTION: Patients receive:\> 300 mg ofatumumab IV over 2-8 hours on day 1, cycle1 and 1000 mg ofatumumab IV on day 1, cycle 2-6 and 90 mg/m2 bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy. \>
\> MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive 1000 mg ofatumumab IV over 2-8 hours on day 1. Treatment repeats every 56 days for up to 4 courses.
|
Arm B (Ofatumumab, Bendamustine Hydrochloride, Bortezomib)
n=62 Participants
INDUCTION: Patients receive 300 mg ofatumumab IV over 2-8 hours on day 1, cycle1 and 1000 mg ofatumumab IV on day 1, cycle 2-6 and 90 mg/m2 bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, and 1.6 mg/m2 bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy. \>
\> MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive 1000 mg ofatumumab IV over 2-8 hours on day 1 and 1.6 mg/m2 bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 56 days for up to 4 courses.
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
61.5 years
n=20 Participants
|
61 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
32 Participants
n=20 Participants
|
60 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
30 Participants
n=20 Participants
|
68 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=5 Participants
|
56 Participants
n=20 Participants
|
118 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
58 Participants
n=20 Participants
|
112 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
4 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=5 Participants
|
62 participants
n=20 Participants
|
128 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until patient stops treatment for any reason, up to 484 days post-randomizationPopulation: All patients that were eligible for response assessment were included in this analysis.
A complete response was defined using International Harmonization Project Response Criteria as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. If the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. The complete response (CR) rate was calculated in newly diagnosed untreated follicular lymphoma patients receiving 6 cycles of ofatumumab-bendamustine (ARM A) and 6 cycles of ofatumumab, bortezomib, and bendamustine (ARM B). The complete response rate was calculated as the number of patients with a complete response divided by the number of patients eligible for evaluation.
Outcome measures
| Measure |
Arm A (Ofatumumab, Bendamustine Hydrochloride)
n=66 Participants
INDUCTION: Patients receive:
300 mg ofatumumab IV over 2-8 hours on day 1, cycle1 and 1000 mg ofatumumab IV on day 1, cycle 2-6 and 90 mg/m2 bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy.
MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive 1000 mg ofatumumab IV over 2-8 hours on day 1. Treatment repeats every 56 days for up to 4 courses.
|
Arm B (Ofatumumab, Bendamustine Hydrochloride, Bortezomib)
n=62 Participants
INDUCTION: Patients receive 300 mg ofatumumab IV over 2-8 hours on day 1, cycle1 and 1000 mg ofatumumab IV on day 1, cycle 2-6 and 90 mg/m2 bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, and 1.6 mg/m2 bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy.
MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive 1000 mg ofatumumab IV over 2-8 hours on day 1 and 1.6 mg/m2 bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 56 days for up to 4 courses.
|
|---|---|---|
|
Complete Response Rate
|
.621 proportion of patients
|
.597 proportion of patients
|
SECONDARY outcome
Timeframe: Up to 4 yearsProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. PFS rates (percentages) at 1, 2, ,3 and 4 years are defined as the percentage of patients who are alive and progression-free at the respective time points. The p-values of the log-rank test will be calculated to compare PFS between the two arms.
Outcome measures
| Measure |
Arm A (Ofatumumab, Bendamustine Hydrochloride)
n=66 Participants
INDUCTION: Patients receive:
300 mg ofatumumab IV over 2-8 hours on day 1, cycle1 and 1000 mg ofatumumab IV on day 1, cycle 2-6 and 90 mg/m2 bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy.
MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive 1000 mg ofatumumab IV over 2-8 hours on day 1. Treatment repeats every 56 days for up to 4 courses.
|
Arm B (Ofatumumab, Bendamustine Hydrochloride, Bortezomib)
n=62 Participants
INDUCTION: Patients receive 300 mg ofatumumab IV over 2-8 hours on day 1, cycle1 and 1000 mg ofatumumab IV on day 1, cycle 2-6 and 90 mg/m2 bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, and 1.6 mg/m2 bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy.
MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive 1000 mg ofatumumab IV over 2-8 hours on day 1 and 1.6 mg/m2 bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 56 days for up to 4 courses.
|
|---|---|---|
|
Progression-free Survival (PFS)
PFS at 1 year
|
93.8 percentage of patients
Interval 88.2 to 99.9
|
84.8 percentage of patients
Interval 76.2 to 94.5
|
|
Progression-free Survival (PFS)
PFS at 2 years
|
80.3 percentage of patients
Interval 70.8 to 91.0
|
75.6 percentage of patients
Interval 65.2 to 87.7
|
|
Progression-free Survival (PFS)
PFS at 3 years
|
65.9 percentage of patients
Interval 53.9 to 80.7
|
67.1 percentage of patients
Interval 55.5 to 81.0
|
|
Progression-free Survival (PFS)
PFS at 4 years
|
57.3 percentage of patients
Interval 43.2 to 75.9
|
64.7 percentage of patients
Interval 52.8 to 79.2
|
SECONDARY outcome
Timeframe: From date of randomization until patient stops treatment for any reason, up to 484 days post-randomizationThe number of patients who experienced grade 3+ hematologic and non-hematologic adverse events at least possibly related to treatment assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Outcome measures
| Measure |
Arm A (Ofatumumab, Bendamustine Hydrochloride)
n=66 Participants
INDUCTION: Patients receive:
300 mg ofatumumab IV over 2-8 hours on day 1, cycle1 and 1000 mg ofatumumab IV on day 1, cycle 2-6 and 90 mg/m2 bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy.
MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive 1000 mg ofatumumab IV over 2-8 hours on day 1. Treatment repeats every 56 days for up to 4 courses.
|
Arm B (Ofatumumab, Bendamustine Hydrochloride, Bortezomib)
n=62 Participants
INDUCTION: Patients receive 300 mg ofatumumab IV over 2-8 hours on day 1, cycle1 and 1000 mg ofatumumab IV on day 1, cycle 2-6 and 90 mg/m2 bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, and 1.6 mg/m2 bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy.
MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive 1000 mg ofatumumab IV over 2-8 hours on day 1 and 1.6 mg/m2 bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 56 days for up to 4 courses.
|
|---|---|---|
|
The Number of Patients Who Experienced Grade 3+ Hematologic and Non-hematologic Adverse Events at Least Possibly Related to Treatment
Hematologic
|
45 Participants
|
41 Participants
|
|
The Number of Patients Who Experienced Grade 3+ Hematologic and Non-hematologic Adverse Events at Least Possibly Related to Treatment
Non-Hematologic
|
17 Participants
|
33 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 10 yearsThe PFS will be compared among the three genotype groups of each SNP using the log-rank tests. A maxtype test will be used by taking the maximum value of the log-rank tests under dominant, recessive, and proportional hazard model. The critical value (or p-value) of the max test will be obtained by a permutation method. No multiple testing adjustment may be applied because of the small sample size.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 10 yearsThe IHC markers will be correlated with response (using the two-sample t-test) and PFS (using the Cox regression method) data. No multiple testing adjustment will be applied because of the small sample size.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 36-38 weeks (6-8 weeks after course 6, day 1 after last course of induction chemotherapy)The ratio will be correlated with response (using the two-sample t-test) and PFS (using the Cox regression method) data.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (Ofatumumab, Bendamustine Hydrochloride)
Serious events: 1 serious events
Other events: 67 other events
Deaths: 1 deaths
Arm B (Ofatumumab, Bendamustine Hydrochloride, Bortezomib)
Serious events: 4 serious events
Other events: 65 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Arm A (Ofatumumab, Bendamustine Hydrochloride)
n=67 participants at risk
INDUCTION: Patients receive:
300 mg ofatumumab IV over 2-8 hours on day 1, cycle1 and 1000 mg ofatumumab IV on day 1, cycle 2-6 and 90 mg/m2 bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy.
MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive 1000 mg ofatumumab IV over 2-8 hours on day 1. Treatment repeats every 56 days for up to 4 courses.
|
Arm B (Ofatumumab, Bendamustine Hydrochloride, Bortezomib)
n=65 participants at risk
INDUCTION: Patients receive 300 mg ofatumumab IV over 2-8 hours on day 1, cycle1 and 1000 mg ofatumumab IV on day 1, cycle 2-6 and 90 mg/m2 bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, and 1.6 mg/m2 bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy.
MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive 1000 mg ofatumumab IV over 2-8 hours on day 1 and 1.6 mg/m2 bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 56 days for up to 4 courses.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
General disorders
Death NOS
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Infections and infestations
Sepsis
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
Other adverse events
| Measure |
Arm A (Ofatumumab, Bendamustine Hydrochloride)
n=67 participants at risk
INDUCTION: Patients receive:
300 mg ofatumumab IV over 2-8 hours on day 1, cycle1 and 1000 mg ofatumumab IV on day 1, cycle 2-6 and 90 mg/m2 bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy.
MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive 1000 mg ofatumumab IV over 2-8 hours on day 1. Treatment repeats every 56 days for up to 4 courses.
|
Arm B (Ofatumumab, Bendamustine Hydrochloride, Bortezomib)
n=65 participants at risk
INDUCTION: Patients receive 300 mg ofatumumab IV over 2-8 hours on day 1, cycle1 and 1000 mg ofatumumab IV on day 1, cycle 2-6 and 90 mg/m2 bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, and 1.6 mg/m2 bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 35 days for up to 6 courses. Patients without disease progression continue on to maintenance therapy.
MAINTENANCE: Beginning 8 weeks after the start of induction course 6, patients receive 1000 mg ofatumumab IV over 2-8 hours on day 1 and 1.6 mg/m2 bortezomib IV over 3-5 seconds or SC on days 1, 8, 15, and 22. Treatment repeats every 56 days for up to 4 courses.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fracture
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
4.6%
3/65 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Investigations
GGT increased
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Investigations
INR increased
|
4.5%
3/67 • Number of events 7 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Investigations
Investigations - Other, specify
|
4.5%
3/67 • Number of events 9 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
4.6%
3/65 • Number of events 7 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Investigations
Lipase increased
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Investigations
Lymphocyte count decreased
|
71.6%
48/67 • Number of events 284 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
67.7%
44/65 • Number of events 218 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Investigations
Lymphocyte count increased
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
4.6%
3/65 • Number of events 14 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Investigations
Neutrophil count decreased
|
59.7%
40/67 • Number of events 130 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
53.8%
35/65 • Number of events 119 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Investigations
Platelet count decreased
|
47.8%
32/67 • Number of events 140 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
53.8%
35/65 • Number of events 136 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Investigations
Weight gain
|
7.5%
5/67 • Number of events 11 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
6.2%
4/65 • Number of events 10 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Investigations
Weight loss
|
10.4%
7/67 • Number of events 15 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
12.3%
8/65 • Number of events 19 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Investigations
White blood cell decreased
|
55.2%
37/67 • Number of events 198 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
66.2%
43/65 • Number of events 183 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Metabolism and nutrition disorders
Anorexia
|
23.9%
16/67 • Number of events 42 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
27.7%
18/65 • Number of events 54 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.0%
6/67 • Number of events 8 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
13.8%
9/65 • Number of events 16 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
7.5%
5/67 • Number of events 11 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
10.8%
7/65 • Number of events 16 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
41.8%
28/67 • Number of events 135 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
38.5%
25/65 • Number of events 78 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.5%
5/67 • Number of events 9 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
6.2%
4/65 • Number of events 4 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.0%
2/67 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.5%
1/67 • Number of events 4 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
6.0%
4/67 • Number of events 8 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
9.2%
6/65 • Number of events 16 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.5%
5/67 • Number of events 9 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
16.9%
11/65 • Number of events 16 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.9%
10/67 • Number of events 20 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
16.9%
11/65 • Number of events 23 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.5%
3/67 • Number of events 6 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
7.7%
5/65 • Number of events 11 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
13.4%
9/67 • Number of events 20 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
24.6%
16/65 • Number of events 22 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.0%
4/67 • Number of events 11 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
9.2%
6/65 • Number of events 11 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.4%
7/67 • Number of events 14 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
18.5%
12/65 • Number of events 14 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.0%
2/67 • Number of events 9 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
4.6%
3/65 • Number of events 5 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.9%
10/67 • Number of events 28 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
13.8%
9/65 • Number of events 22 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Nervous system disorders
Headache
|
20.9%
14/67 • Number of events 42 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
27.7%
18/65 • Number of events 43 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Nervous system disorders
Lethargy
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Nervous system disorders
Memory impairment
|
4.5%
3/67 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
6.2%
4/65 • Number of events 5 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Nervous system disorders
Movements involuntary
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Psychiatric disorders
Anxiety
|
19.4%
13/67 • Number of events 47 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
24.6%
16/65 • Number of events 28 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Psychiatric disorders
Confusion
|
3.0%
2/67 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
4.6%
3/65 • Number of events 5 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Vomiting
|
17.9%
12/67 • Number of events 20 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
50.8%
33/65 • Number of events 57 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
General disorders
Chills
|
11.9%
8/67 • Number of events 9 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
27.7%
18/65 • Number of events 32 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
General disorders
Edema face
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
General disorders
Edema limbs
|
16.4%
11/67 • Number of events 16 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
13.8%
9/65 • Number of events 19 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
General disorders
Edema trunk
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
General disorders
Facial pain
|
1.5%
1/67 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
General disorders
Fatigue
|
73.1%
49/67 • Number of events 241 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
70.8%
46/65 • Number of events 207 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
General disorders
Fever
|
16.4%
11/67 • Number of events 16 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
36.9%
24/65 • Number of events 35 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
General disorders
Flu like symptoms
|
3.0%
2/67 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
6.2%
4/65 • Number of events 4 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
General disorders
Gait disturbance
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Immune system disorders
Cytokine release syndrome
|
14.9%
10/67 • Number of events 11 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
9.2%
6/65 • Number of events 8 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Infections and infestations
Peripheral nerve infection
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Infections and infestations
Sepsis
|
3.0%
2/67 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Infections and infestations
Sinusitis
|
10.4%
7/67 • Number of events 9 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Infections and infestations
Skin infection
|
6.0%
4/67 • Number of events 6 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
10.8%
7/65 • Number of events 9 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Infections and infestations
Small intestine infection
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Infections and infestations
Tooth infection
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Infections and infestations
Upper respiratory infection
|
17.9%
12/67 • Number of events 26 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
10.8%
7/65 • Number of events 16 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Infections and infestations
Urinary tract infection
|
10.4%
7/67 • Number of events 8 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
7.7%
5/65 • Number of events 6 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Injury, poisoning and procedural complications
Bruising
|
6.0%
4/67 • Number of events 8 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
6.2%
4/65 • Number of events 4 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Psychiatric disorders
Insomnia
|
25.4%
17/67 • Number of events 50 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
20.0%
13/65 • Number of events 50 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Psychiatric disorders
Libido decreased
|
1.5%
1/67 • Number of events 8 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Renal and urinary disorders
Urinary retention
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Renal and urinary disorders
Urinary tract pain
|
3.0%
2/67 • Number of events 9 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.9%
8/67 • Number of events 18 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
9.2%
6/65 • Number of events 13 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Psychiatric disorders
Delirium
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Psychiatric disorders
Depression
|
10.4%
7/67 • Number of events 13 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
6.2%
4/65 • Number of events 10 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Cardiac disorders
Sinus tachycardia
|
4.5%
3/67 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
6.2%
4/65 • Number of events 5 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 8 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
6.2%
4/65 • Number of events 5 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Ear and labyrinth disorders
External ear inflammation
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Ear and labyrinth disorders
Hearing impaired
|
1.5%
1/67 • Number of events 6 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.5%
1/67 • Number of events 4 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Endocrine disorders
Hypothyroidism
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Eye disorders
Blurred vision
|
6.0%
4/67 • Number of events 16 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
15.4%
10/65 • Number of events 27 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Eye disorders
Cataract
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
6.2%
4/65 • Number of events 6 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Eye disorders
Dry eye
|
3.0%
2/67 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
9.2%
6/65 • Number of events 12 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Eye disorders
Extraocular muscle paresis
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Eye disorders
Eye disorders - Other, specify
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
6.2%
4/65 • Number of events 5 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Eye disorders
Eye pain
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Eye disorders
Flashing lights
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Eye disorders
Floaters
|
1.5%
1/67 • Number of events 6 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Eye disorders
Photophobia
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 4 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Eye disorders
Watering eyes
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
31.3%
21/67 • Number of events 37 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
20.0%
13/65 • Number of events 27 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Anal fistula
|
1.5%
1/67 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Bloating
|
3.0%
2/67 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Constipation
|
37.3%
25/67 • Number of events 71 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
52.3%
34/65 • Number of events 130 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Dental caries
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Diarrhea
|
32.8%
22/67 • Number of events 61 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
60.0%
39/65 • Number of events 116 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Dry mouth
|
3.0%
2/67 • Number of events 13 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
9.2%
6/65 • Number of events 28 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Dyspepsia
|
22.4%
15/67 • Number of events 38 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
16.9%
11/65 • Number of events 28 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Dysphagia
|
6.0%
4/67 • Number of events 7 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Esophageal pain
|
4.5%
3/67 • Number of events 6 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Flatulence
|
6.0%
4/67 • Number of events 8 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 6 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.5%
5/67 • Number of events 16 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
6.2%
4/65 • Number of events 5 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
3.0%
2/67 • Number of events 9 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.5%
1/67 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Ileus
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Mucositis oral
|
16.4%
11/67 • Number of events 12 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
13.8%
9/65 • Number of events 11 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Nausea
|
58.2%
39/67 • Number of events 125 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
84.6%
55/65 • Number of events 192 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Oral pain
|
6.0%
4/67 • Number of events 11 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Rectal pain
|
3.0%
2/67 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Gastrointestinal disorders
Stomach pain
|
3.0%
2/67 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Cardiac disorders
Palpitations
|
3.0%
2/67 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Cardiac disorders
Pericarditis
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Blood and lymphatic system disorders
Anemia
|
44.8%
30/67 • Number of events 141 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
61.5%
40/65 • Number of events 149 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
4.6%
3/65 • Number of events 6 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 4 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Cardiac disorders
Chest pain - cardiac
|
3.0%
2/67 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Cardiac disorders
Myocardial infarction
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
4.6%
3/65 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
General disorders
Infusion related reaction
|
22.4%
15/67 • Number of events 19 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
20.0%
13/65 • Number of events 16 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
General disorders
Infusion site extravasation
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
General disorders
Injection site reaction
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
General disorders
Irritability
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
General disorders
Localized edema
|
1.5%
1/67 • Number of events 6 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
4.6%
3/65 • Number of events 4 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
General disorders
Malaise
|
6.0%
4/67 • Number of events 4 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
General disorders
Non-cardiac chest pain
|
3.0%
2/67 • Number of events 5 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
4.6%
3/65 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
General disorders
Pain
|
14.9%
10/67 • Number of events 19 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
26.2%
17/65 • Number of events 42 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.5%
1/67 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Immune system disorders
Allergic reaction
|
40.3%
27/67 • Number of events 35 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
46.2%
30/65 • Number of events 37 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Immune system disorders
Anaphylaxis
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Immune system disorders
Immune system disorders - Other, specify
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Infections and infestations
Anorectal infection
|
1.5%
1/67 • Number of events 5 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Infections and infestations
Bladder infection
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Infections and infestations
Cecal infection
|
1.5%
1/67 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Infections and infestations
Conjunctivitis infective
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Infections and infestations
Eye infection
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
6.2%
4/65 • Number of events 11 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
9.0%
6/67 • Number of events 8 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
12.3%
8/65 • Number of events 11 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Infections and infestations
Lung infection
|
4.5%
3/67 • Number of events 4 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
6.2%
4/65 • Number of events 4 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Infections and infestations
Nail infection
|
3.0%
2/67 • Number of events 5 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Infections and infestations
Otitis media
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Infections and infestations
Paronychia
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 9 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Investigations
Alanine aminotransferase increased
|
29.9%
20/67 • Number of events 75 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
15.4%
10/65 • Number of events 23 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Investigations
Alkaline phosphatase increased
|
7.5%
5/67 • Number of events 11 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
9.2%
6/65 • Number of events 11 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Investigations
Aspartate aminotransferase increased
|
35.8%
24/67 • Number of events 61 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
21.5%
14/65 • Number of events 52 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Investigations
Blood bilirubin increased
|
11.9%
8/67 • Number of events 15 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
7.7%
5/65 • Number of events 15 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Investigations
Cardiac troponin I increased
|
1.5%
1/67 • Number of events 4 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Investigations
Cholesterol high
|
1.5%
1/67 • Number of events 5 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
4.6%
3/65 • Number of events 7 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Investigations
Creatinine increased
|
17.9%
12/67 • Number of events 32 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
21.5%
14/65 • Number of events 42 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Investigations
Ejection fraction decreased
|
3.0%
2/67 • Number of events 5 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
6.0%
4/67 • Number of events 17 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
4.6%
3/65 • Number of events 4 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.4%
13/67 • Number of events 45 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
15.4%
10/65 • Number of events 20 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.4%
11/67 • Number of events 22 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
23.1%
15/65 • Number of events 42 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.4%
7/67 • Number of events 14 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
9.2%
6/65 • Number of events 15 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
3.0%
2/67 • Number of events 5 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
11.9%
8/67 • Number of events 26 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
10.8%
7/65 • Number of events 18 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased cervical spine
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
4.5%
3/67 • Number of events 14 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 4 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
9.0%
6/67 • Number of events 12 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
6.2%
4/65 • Number of events 8 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.4%
17/67 • Number of events 43 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
12.3%
8/65 • Number of events 24 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
6.0%
4/67 • Number of events 5 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Nervous system disorders
Akathisia
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Nervous system disorders
Amnesia
|
1.5%
1/67 • Number of events 6 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Nervous system disorders
Concentration impairment
|
1.5%
1/67 • Number of events 8 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Nervous system disorders
Dizziness
|
22.4%
15/67 • Number of events 24 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
26.2%
17/65 • Number of events 36 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Nervous system disorders
Dysgeusia
|
16.4%
11/67 • Number of events 30 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
9.2%
6/65 • Number of events 19 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Nervous system disorders
Facial muscle weakness
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
1.5%
1/67 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Nervous system disorders
Neuralgia
|
1.5%
1/67 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
6.2%
4/65 • Number of events 12 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Nervous system disorders
Olfactory nerve disorder
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Nervous system disorders
Paresthesia
|
3.0%
2/67 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
10.8%
7/65 • Number of events 10 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
23.9%
16/67 • Number of events 62 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
55.4%
36/65 • Number of events 146 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Nervous system disorders
Sinus pain
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Nervous system disorders
Somnolence
|
1.5%
1/67 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Nervous system disorders
Syncope
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
4.6%
3/65 • Number of events 5 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Nervous system disorders
Tremor
|
3.0%
2/67 • Number of events 11 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Pregnancy, puerperium and perinatal conditions
Unintended pregnancy
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Psychiatric disorders
Suicidal ideation
|
1.5%
1/67 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.0%
2/67 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Renal and urinary disorders
Hematuria
|
1.5%
1/67 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
4.6%
3/65 • Number of events 4 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Renal and urinary disorders
Proteinuria
|
3.0%
2/67 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
7.7%
5/65 • Number of events 6 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Renal and urinary disorders
Urinary frequency
|
4.5%
3/67 • Number of events 7 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
9.0%
6/67 • Number of events 11 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
6.2%
4/65 • Number of events 6 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.3%
21/67 • Number of events 47 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
27.7%
18/65 • Number of events 41 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.4%
15/67 • Number of events 38 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
24.6%
16/65 • Number of events 46 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.0%
2/67 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 4 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.0%
2/67 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.0%
2/67 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.0%
2/67 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
7.7%
5/65 • Number of events 7 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.0%
2/67 • Number of events 5 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
10.8%
7/65 • Number of events 12 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.5%
1/67 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
3.0%
2/67 • Number of events 6 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
4.5%
3/67 • Number of events 5 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
10.4%
7/67 • Number of events 7 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
7.7%
5/65 • Number of events 5 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.5%
3/67 • Number of events 7 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 6 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.5%
1/67 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.5%
1/67 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
4.6%
3/65 • Number of events 12 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
1.5%
1/67 • Number of events 5 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.5%
5/67 • Number of events 21 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
18.5%
12/65 • Number of events 17 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.0%
2/67 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
4.6%
3/65 • Number of events 6 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
31.3%
21/67 • Number of events 48 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
38.5%
25/65 • Number of events 51 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
9.0%
6/67 • Number of events 9 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
7.7%
5/65 • Number of events 6 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.5%
3/67 • Number of events 3 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
6.2%
4/65 • Number of events 4 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
0.00%
0/65 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Vascular disorders
Flushing
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Vascular disorders
Hot flashes
|
6.0%
4/67 • Number of events 12 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
9.2%
6/65 • Number of events 16 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Vascular disorders
Hypertension
|
26.9%
18/67 • Number of events 79 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
20.0%
13/65 • Number of events 42 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Vascular disorders
Hypotension
|
7.5%
5/67 • Number of events 9 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
18.5%
12/65 • Number of events 17 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Vascular disorders
Phlebitis
|
1.5%
1/67 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
3.1%
2/65 • Number of events 4 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Vascular disorders
Superficial thrombophlebitis
|
1.5%
1/67 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 2 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Vascular disorders
Thromboembolic event
|
4.5%
3/67 • Number of events 4 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
1.5%
1/65 • Number of events 1 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/67 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
6.2%
4/65 • Number of events 7 • Adverse events were collected systematically after each cycle, up to 10 cycles. Cycles 1-6 were up to 35 days and cycles 7-10 were up to 56 days.
|
Additional Information
Kristie A. Blum, MD
Alliance for Clinical Trials in Oncology
Phone: 614-293-8858
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60