Trial Outcomes & Findings for Duvelisib and Venetoclax in Relapsed or Refractory CLL or SLL or RS (NCT NCT03534323)
NCT ID: NCT03534323
Last Updated: 2026-03-23
Results Overview
The overall response rate (ORR) was defined as the proportion of participants achieving complete response (CR) based on IWCLL 2008 and Lugano 2014 criteria for RS.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
55 participants
Primary outcome timeframe
Response assessment on the end of cycle 3, 6 and 13. With 28 days per cycle.
Results posted on
2026-03-23
Participant Flow
Participant milestones
| Measure |
Phase 1 Level 1: 100 mg Venetoclax (Daily) + 25 mg Duvelisib (BID)
Duvelisib will be given alone for the first seven days. On day 8 Venetoclax will be added.
Duvelisib will be administered orally twice daily of 25mg Venetoclax will be administered orally daily of 100mg All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation
|
Phase 1 Level 2: 200 mg Venetoclax (Daily) + 25 mg Duvelisib (BID)
Duvelisib will be administered orally twice daily of 25mg Venetoclax will be administered orally daily of 200mg All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation
|
Phase 1 Level 3: 400 mg Venetoclax (Daily) + 25 mg Duvelisib (BID)
Duvelisib will be administered orally twice daily of 25mg Venetoclax will be administered orally daily of 400mg All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation
|
Phase 2: 400 mg Venetoclax (Daily) + 25 mg Duvelisib (BID)
Duvelisib will be administered orally twice daily of 25mg Venetoclax will be administered orally daily of 400mg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
32
|
|
Overall Study
Death
|
0
|
1
|
1
|
3
|
|
Overall Study
Subject Started a New Systemic Therapy
|
3
|
0
|
0
|
4
|
|
Overall Study
Lost to Follow Up
|
0
|
1
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
3
|
|
Overall Study
COMPLETED
|
0
|
1
|
5
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
1
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Duvelisib and Venetoclax in Relapsed or Refractory CLL or SLL or RS
Baseline characteristics by cohort
| Measure |
Phase 1 Level 1: 100 mg Venetoclax (Daily) + 25 mg Duvelisib (BID)
n=3 Participants
Duvelisib will be given alone for the first seven days. On day 8 Venetoclax will be added.
Duvelisib will be administered orally twice daily of 25mg Venetoclax will be administered orally daily of 100mg All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation
|
Phase 1 Level 2: 200 mg Venetoclax (Daily) + 25 mg Duvelisib (BID)
n=3 Participants
Duvelisib will be administered orally twice daily of 25mg Venetoclax will be administered orally daily of 200mg All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation
|
Phase 1 Level 3: 400 mg Venetoclax (Daily) + 25 mg Duvelisib (BID)
n=6 Participants
Duvelisib will be administered orally twice daily of 25mg Venetoclax will be administered orally daily of 400mg All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation
|
Phase 2: 400 mg Venetoclax (Daily) + 25 mg Duvelisib (BID)
n=32 Participants
Duvelisib will be administered orally twice daily of 25mg Venetoclax will be administered orally daily of 400mg
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
66 years
n=10 Participants
|
70 years
n=8 Participants
|
71 years
n=18 Participants
|
65 years
n=158 Participants
|
67 years
n=3 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=18 Participants
|
10 Participants
n=158 Participants
|
13 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=10 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=18 Participants
|
22 Participants
n=158 Participants
|
31 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=10 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=158 Participants
|
3 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=10 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=18 Participants
|
31 Participants
n=158 Participants
|
41 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=10 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=18 Participants
|
32 Participants
n=158 Participants
|
44 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=10 Participants
|
3 participants
n=8 Participants
|
6 participants
n=18 Participants
|
32 participants
n=158 Participants
|
44 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Response assessment on the end of cycle 3, 6 and 13. With 28 days per cycle.Population: CR is not reported by dose level because Phase I is a safety-driven 3+3 design with very small cohorts that are not powered for efficacy comparisons. The trial is statistically designed to evaluate CR at the recommended Phase II dose, so combining patients treated at the MTD provides the clinically interpretable estimate while avoiding unreliable, underpowered subgroup comparisons.
The overall response rate (ORR) was defined as the proportion of participants achieving complete response (CR) based on IWCLL 2008 and Lugano 2014 criteria for RS.
Outcome measures
| Measure |
Venetoclax (Daily) + Duvelisib (BID)
n=35 Participants
Duvelisib will be given alone for the first seven days. On day 8 Venetoclax will be added.
* Duvelisib will be administered orally twice daily
* Venetoclax will be administered orally daily
* All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation
Duvelisib: This drug is designed to stop cancer growth by blocking a protein called phosphatidylinositide 3-kinase (PI3K), which is important for the survival of CLL cells.
Venetoclax: Venetoclax targets a protein called BCL-2, which helps cancer cells survive.
|
|---|---|
|
Complete Response Rate (CRR)
cycle 3
|
0.11 proportion of participants
Interval 0.03 to 0.27
|
|
Complete Response Rate (CRR)
cycle 6
|
0.31 proportion of participants
Interval 0.17 to 0.49
|
|
Complete Response Rate (CRR)
cycle 13
|
0.34 proportion of participants
Interval 0.19 to 0.52
|
PRIMARY outcome
Timeframe: Response assessment on the end of cycle 3, 6 and 13. With 28 days per cycle.Population: CR is not reported by dose level because Phase I is a safety-driven 3+3 design with very small cohorts that are not powered for efficacy comparisons. The trial is statistically designed to evaluate OR at the recommended Phase II dose, so combining patients treated at the MTD provides the clinically interpretable estimate while avoiding unreliable, underpowered subgroup comparisons.
The overall response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on IWCLL 2008 and Lugano 2014 criteria for RS.
Outcome measures
| Measure |
Venetoclax (Daily) + Duvelisib (BID)
n=35 Participants
Duvelisib will be given alone for the first seven days. On day 8 Venetoclax will be added.
* Duvelisib will be administered orally twice daily
* Venetoclax will be administered orally daily
* All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation
Duvelisib: This drug is designed to stop cancer growth by blocking a protein called phosphatidylinositide 3-kinase (PI3K), which is important for the survival of CLL cells.
Venetoclax: Venetoclax targets a protein called BCL-2, which helps cancer cells survive.
|
|---|---|
|
Overall Response Rate (ORR)
cycle 3
|
0.82 Proportion of participants
Interval 0.67 to 0.92
|
|
Overall Response Rate (ORR)
cycle 6
|
0.69 Proportion of participants
Interval 0.51 to 0.82
|
|
Overall Response Rate (ORR)
cycle 13
|
0.6 Proportion of participants
Interval 0.43 to 0.75
|
SECONDARY outcome
Timeframe: Relevant to this endpoint is at 12 month.Population: PFS and OS are not reported by dose level because the 3+3 design produces very small, sequential cohorts with unequal follow-up and potential dose escalation. Time-to-event estimates would be unstable, biased, and uninterpretable. The study is designed to evaluate survival outcomes at the recommended Phase II dose, not to compare survival across dose levels.
Progression-free survival based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) or death, or is censored at time of last disease assessment.
Outcome measures
| Measure |
Venetoclax (Daily) + Duvelisib (BID)
n=35 Participants
Duvelisib will be given alone for the first seven days. On day 8 Venetoclax will be added.
* Duvelisib will be administered orally twice daily
* Venetoclax will be administered orally daily
* All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation
Duvelisib: This drug is designed to stop cancer growth by blocking a protein called phosphatidylinositide 3-kinase (PI3K), which is important for the survival of CLL cells.
Venetoclax: Venetoclax targets a protein called BCL-2, which helps cancer cells survive.
|
|---|---|
|
12-month Progression-Free Survival (PFS) Rate
|
0.69 probability
Interval 0.56 to 0.85
|
SECONDARY outcome
Timeframe: Relevant to this endpoint is 1 year.Population: PFS and OS are not reported by dose level because the 3+3 design produces very small, sequential cohorts with unequal follow-up and potential dose escalation. Time-to-event estimates would be unstable, biased, and uninterpretable. The study is designed to evaluate survival outcomes at the recommended Phase II dose, not to compare survival across dose levels.
1-year OS is a probability estimated using the Kaplan-Meier method; OS is defined as the time from study entry to death, or censored at date last known alive.
Outcome measures
| Measure |
Venetoclax (Daily) + Duvelisib (BID)
n=35 Participants
Duvelisib will be given alone for the first seven days. On day 8 Venetoclax will be added.
* Duvelisib will be administered orally twice daily
* Venetoclax will be administered orally daily
* All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation
Duvelisib: This drug is designed to stop cancer growth by blocking a protein called phosphatidylinositide 3-kinase (PI3K), which is important for the survival of CLL cells.
Venetoclax: Venetoclax targets a protein called BCL-2, which helps cancer cells survive.
|
|---|---|
|
1-year Overall Survival (OS)
|
0.79 probability
Interval 0.68 to 0.93
|
SECONDARY outcome
Timeframe: At 1 yearPopulation: CR is not reported by dose level because Phase I is a safety-driven 3+3 design with very small cohorts that are not powered for efficacy comparisons. The trial is statistically designed to evaluate the MRD rate at the recommended Phase II dose, so combining patients treated at the MTD provides the clinically interpretable estimate while avoiding unreliable, underpowered subgroup comparisons.
Defined by the proportion of participants achieved the MRD negative CR in bone marrow.
Outcome measures
| Measure |
Venetoclax (Daily) + Duvelisib (BID)
n=35 Participants
Duvelisib will be given alone for the first seven days. On day 8 Venetoclax will be added.
* Duvelisib will be administered orally twice daily
* Venetoclax will be administered orally daily
* All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation
Duvelisib: This drug is designed to stop cancer growth by blocking a protein called phosphatidylinositide 3-kinase (PI3K), which is important for the survival of CLL cells.
Venetoclax: Venetoclax targets a protein called BCL-2, which helps cancer cells survive.
|
|---|---|
|
1-year MRD Negativity Rate
|
0.29 proportion of participants
Interval 0.15 to 0.46
|
Adverse Events
Phase 1 Level 1: 100 mg Venetoclax (Daily) + 25 mg Duvelisib (BID)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1 Level 2: 200 mg Venetoclax (Daily) + 25 mg Duvelisib (BID)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1 Level 3: 400 mg Venetoclax (Daily) + 25 mg Duvelisib (BID)
Serious events: 6 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase 2: 400 mg Venetoclax (Daily) + 25 mg Duvelisib (BID)
Serious events: 28 serious events
Other events: 31 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Phase 1 Level 1: 100 mg Venetoclax (Daily) + 25 mg Duvelisib (BID)
n=3 participants at risk
Duvelisib will be given alone for the first seven days. On day 8 Venetoclax will be added.
Duvelisib will be administered orally twice daily of 25mg Venetoclax will be administered orally daily of 100mg All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation
|
Phase 1 Level 2: 200 mg Venetoclax (Daily) + 25 mg Duvelisib (BID)
n=3 participants at risk
Duvelisib will be administered orally twice daily of 25mg Venetoclax will be administered orally daily of 200mg All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation
|
Phase 1 Level 3: 400 mg Venetoclax (Daily) + 25 mg Duvelisib (BID)
n=6 participants at risk
Duvelisib will be administered orally twice daily of 25mg Venetoclax will be administered orally daily of 400mg All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation
|
Phase 2: 400 mg Venetoclax (Daily) + 25 mg Duvelisib (BID)
n=32 participants at risk
Duvelisib will be administered orally twice daily of 25mg Venetoclax will be administered orally daily of 400mg
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
2/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
15.6%
5/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Investigations
Lipase increased
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Investigations
Lymphocyte count decreased
|
66.7%
2/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
66.7%
2/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Investigations
Neutrophil count decreased
|
100.0%
3/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
66.7%
2/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
83.3%
5/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
78.1%
25/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Investigations
Serum amylase increased
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Investigations
White blood cell decreased
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
100.0%
3/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
9.4%
3/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
2/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
15.6%
5/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
General disorders
Fatigue
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
9.4%
3/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
28.1%
9/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
Other adverse events
| Measure |
Phase 1 Level 1: 100 mg Venetoclax (Daily) + 25 mg Duvelisib (BID)
n=3 participants at risk
Duvelisib will be given alone for the first seven days. On day 8 Venetoclax will be added.
Duvelisib will be administered orally twice daily of 25mg Venetoclax will be administered orally daily of 100mg All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation
|
Phase 1 Level 2: 200 mg Venetoclax (Daily) + 25 mg Duvelisib (BID)
n=3 participants at risk
Duvelisib will be administered orally twice daily of 25mg Venetoclax will be administered orally daily of 200mg All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation
|
Phase 1 Level 3: 400 mg Venetoclax (Daily) + 25 mg Duvelisib (BID)
n=6 participants at risk
Duvelisib will be administered orally twice daily of 25mg Venetoclax will be administered orally daily of 400mg All patients will be admitted for administration of the initial dose of venetoclax at each dose escalation
|
Phase 2: 400 mg Venetoclax (Daily) + 25 mg Duvelisib (BID)
n=32 participants at risk
Duvelisib will be administered orally twice daily of 25mg Venetoclax will be administered orally daily of 400mg
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
66.7%
2/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
2/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
18.8%
6/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
2/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
15.6%
5/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
9.4%
3/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Gastrointestinal disorders
Hemorrhoids
|
66.7%
2/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
9.4%
3/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
General disorders
Chills
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
2/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
General disorders
Fatigue
|
100.0%
3/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
100.0%
3/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
66.7%
4/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
40.6%
13/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
General disorders
Fever
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
12.5%
4/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Infections and infestations
Lung infection
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Injury, poisoning and procedural complications
Bruising
|
66.7%
2/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
12.5%
4/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Investigations
Alkaline phosphatase increased
|
66.7%
2/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
66.7%
2/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
25.0%
8/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Investigations
Creatinine increased
|
66.7%
2/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
18.8%
6/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Investigations
Lymphocyte count increased
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
100.0%
3/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Investigations
Neutrophil count decreased
|
66.7%
2/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
2/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
66.7%
2/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
50.0%
3/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
15.6%
5/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
3/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
100.0%
3/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
100.0%
6/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
21.9%
7/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
66.7%
2/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
66.7%
2/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
2/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
66.7%
2/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
100.0%
3/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
100.0%
6/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
50.0%
3/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
100.0%
3/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
2/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
66.7%
4/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
9.4%
3/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
66.7%
2/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
83.3%
5/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
9.4%
3/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
25.0%
8/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
9.4%
3/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
2/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
9.4%
3/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
15.6%
5/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
18.8%
6/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
1/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
25.0%
8/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
66.7%
2/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
9.4%
3/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Eye disorders
Glaucoma
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
General disorders
Edema face
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
General disorders
Malaise
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Investigations
Weight gain
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
33.3%
2/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
9.4%
3/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
12.5%
4/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
50.0%
3/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
15.6%
5/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
18.8%
6/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
9.4%
3/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
16.7%
1/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
9.4%
3/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Eye disorders
Vitreous hemorrhage
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
9.4%
3/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
15.6%
5/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
General disorders
Edema limbs
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
9.4%
3/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
General disorders
Generalized edema
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
General disorders
Localized edema
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
9.4%
3/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
General disorders
Pain
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
9.4%
3/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Infections and infestations
Thrush
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Injury, poisoning and procedural complications
Urostomy obstruction
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
9.4%
3/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Investigations
INR increased
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Investigations
Serum amylase increased
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Investigations
Weight loss
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
15.6%
5/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
9.4%
3/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
15.6%
5/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
9.4%
3/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
12.5%
4/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
12.5%
4/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
9.4%
3/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
9.4%
3/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
6.2%
2/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
12.5%
4/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
37.5%
12/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/3 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
0.00%
0/6 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
3.1%
1/32 • AE evaluated day 1, 8, 15, 22, 29, 36 and 43 of cycle 1, day 1, 8, 15, 22 of cycle 2, then day of each cycle until the end of treatment. Median number of cycles: 13, range: 1-50. 1 cycle= 28 days.
|
Additional Information
Matthew Davids, MD, MMSc - Principal Investigator
Dana-Farber Cancer Institute
Phone: 617-632-6331
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place