Trial Outcomes & Findings for A Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission (NCT NCT03850535)
NCT ID: NCT03850535
Last Updated: 2022-06-21
Results Overview
Sponsor's decision to prematurely terminate the study was made at the end of the Phase 1. The planned Phase 2 was not initiated. This decision was not based on safety concerns, but rather due to the overall company strategy about the adult AML
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Cycle 1 of induction treatment (1 cycle is 28 days)
Results posted on
2022-06-21
Participant Flow
Participant milestones
| Measure |
Dose-Escalation Cohort 1
200 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
|
Dose Escalation Cohort 2
350 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
|
Dose Escalation Cohort 3
250 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
|
Post Consolidation Cohort
150 mg idasanultin day 1 to 5 in maintenance of first remission
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
9
|
6
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
9
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission
Baseline characteristics by cohort
| Measure |
Dose-Escalation Cohort 1
n=4 Participants
200 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
|
Dose Escalation Cohort 2
n=9 Participants
350 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
|
Dose Escalation Cohort 3
n=6 Participants
250 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
|
Post Consolidation Cohort
n=4 Participants
150 mg idasanultin day 1 to 5 in maintenance of first remission
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49.5 Years
STANDARD_DEVIATION 17.1 • n=99 Participants
|
45.2 Years
STANDARD_DEVIATION 16.9 • n=107 Participants
|
49.8 Years
STANDARD_DEVIATION 14.0 • n=206 Participants
|
64.8 Years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
50.6 Years
STANDARD_DEVIATION 15.6 • n=31 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 of induction treatment (1 cycle is 28 days)Population: ITT Population
Sponsor's decision to prematurely terminate the study was made at the end of the Phase 1. The planned Phase 2 was not initiated. This decision was not based on safety concerns, but rather due to the overall company strategy about the adult AML
Outcome measures
| Measure |
Dose-Escalation Cohort 1
n=4 Participants
200 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
|
Dose Escalation Cohort 2
n=9 Participants
350 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
|
Dose Escalation Cohort 3
n=6 Participants
250 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
|
Post Consolidation Cohort
n=4 Participants
150 mg idasanultin day 1 to 5 in maintenance of first remission
|
|---|---|---|---|---|
|
Dose Escalation Phase: Number of Participants With Dose-Limiting Toxicities (DLTs) During the First Cycle of Induction Treatment
|
2 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Baseline until 28 days after the final dose of study drug (up to 2 years)Population: Safety Population
Sponsor's decision to prematurely terminate the study was made at the end of the Phase 1. The planned Phase 2 was not initiated. This decision was not based on safety concerns, but rather due to the overall company strategy about the adult AML.
Outcome measures
| Measure |
Dose-Escalation Cohort 1
n=4 Participants
200 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
|
Dose Escalation Cohort 2
n=9 Participants
350 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
|
Dose Escalation Cohort 3
n=6 Participants
250 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
|
Post Consolidation Cohort
n=4 Participants
150 mg idasanultin day 1 to 5 in maintenance of first remission
|
|---|---|---|---|---|
|
Number of Participants With at Least One Adverse Event
|
4 Percentage of Participants
|
9 Percentage of Participants
|
6 Percentage of Participants
|
4 Percentage of Participants
|
PRIMARY outcome
Timeframe: From Baseline until 28 days after the final dose of study drug (up to 2 years)Population: Safety Population
Sponsor's decision to prematurely terminate the study was made at the end of the Phase 1. The planned Phase 2 was not initiated. This decision was not based on safety concerns, but rather due to the overall company strategy about the adult AML
Outcome measures
| Measure |
Dose-Escalation Cohort 1
n=4 Participants
200 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
|
Dose Escalation Cohort 2
n=9 Participants
350 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
|
Dose Escalation Cohort 3
n=6 Participants
250 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
|
Post Consolidation Cohort
n=4 Participants
150 mg idasanultin day 1 to 5 in maintenance of first remission
|
|---|---|---|---|---|
|
Number of Participants With Grade ≥3 Adverse Events, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
|
4 Participants
|
9 Participants
|
5 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Day 1 of each treatment cycle (1 cycle is 28 days) and at study drug discontinuation (up to 2 years)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1 of each treatment cycle (1 cycle is 28 days) and at study drug discontinuation (up to 2 years)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1 of each treatment cycle (1 cycle is 28 days) and at study drug discontinuation (up to 2 years)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Day 1 of each treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At the end of induction treatment (up to 2 cycles; 1 cycle is 28 days)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
Sponsor's decision to prematurely terminate the study was made at the end of the Phase 1. This decision was not based on safety concerns, but rather due to the overall company strategy about the adult AML. Therefore this outcome measure was not conducted and no data available to report.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the end of induction treatment (up to 2 cycles; 1 cycle is 28 days)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the end of induction treatment (up to 2 cycles; 1 cycle is 28 days)Population: ITT Population. Analyzed population was the number of participants in Cohorts 1-3 from whom evaluable data were obtained. The Postconsidaltion cohort involved the participants in maintenance and were excluded.
Sponsor's decision to prematurely terminate the study was made at the end of the Phase 1. The planned Phase 2 was not initiated. This decision was not based on safety concerns, but rather due to the overall company strategy about the adult AML. Therefore this outcome measure was not conducted and no data available to report.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the end of induction treatment (up to 2 cycles; 1 cycle is 28 days)Population: ITT Population. Analyzed population was the number of participants in Cohorts 1-3 from whom evaluable data were obtained. The Postconsidaltion cohort involved the participants in maintenance and were excluded.
Sponsor's decision to prematurely terminate the study was made at the end of the Phase 1. The planned Phase 2 was not initiated. This decision was not based on safety concerns, but rather due to the overall company strategy about the adult AML. Therefore this outcome measure was not conducted and no data available to report.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At the end of maintenance treatment (12 cycles, 1 cycle is 28 days)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 1 of each cycle of induction and consolidation (1 cycle is 28 days), every 3 months starting at Cycle 1 of maintenance, and at study drug discontinuation (up to 2 years)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 1 of first induction cycle only, Day 1 of each subsequent treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 1 of first induction cycle only, Day 1 of each subsequent treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 1 of first induction cycle only, Day 1 of each subsequent treatment cycle (1 cycle is 28 days), and at study drug discontinuation (up to 2 years)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 1 of each cycle of induction and consolidation (1 cycle is 28 days), every 3 months starting at Cycle 1 of maintenance, and at study drug discontinuation (up to 2 years)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 1 of each cycle of induction and consolidation (1 cycle is 28 days), every 3 months starting at Cycle 1 of maintenance, and at study drug discontinuation (up to 2 years)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The Sponsor decided not to continue the study based on the overall Company strategy in AML. Due to the limited The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 1 of each cycle of induction and consolidation (1 cycle is 28 days), every 3 months starting at Cycle 1 of maintenance, and at study drug discontinuation (up to 2 years)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 1 of first induction cycle only, Day 1 of all cycles of consolidation (1 cycle is 28 days), every 3 months starting at Cycle 1 of maintenance, and at study drug discontinuation (up to 2 years)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 1 of first induction cycle only, Day 1 of all cycles of consolidation (1 cycle is 28 days), every 3 months starting at Cycle 1 of maintenance, and at study drug discontinuation (up to 2 years)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; Days 1 and 5 of consolidation Cycle 1; and Days 1 and 5 of maintenance Cycle 1 (1 cycle is 28 days)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; and Days 1 and 5 of consolidation Cycle 1 (1 cycle is 28 days)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1 (1 cycle is 28 days)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; Days 1 and 5 of consolidation Cycle 1; and Days 1 and 5 of maintenance Cycle 1 (1 cycle is 28 days)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; and Days 1 and 5 of consolidation Cycle 1 (1 cycle is 28 days)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1 (1 cycle is 28 days)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; Days 1 and 5 of consolidation Cycle 1; and Days 1 and 5 of maintenance Cycle 1 (1 cycle is 28 days)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; and Days 1 and 5 of consolidation Cycle 1 (1 cycle is 28 days)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1 (1 cycle is 28 days)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; Days 1 and 5 of consolidation Cycle 1; and Days 1 and 5 of maintenance Cycle 1 (1 cycle is 28 days)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; and Days 1 and 5 of consolidation Cycle 1 (1 cycle is 28 days)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1 (1 cycle is 28 days)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; Days 1 and 5 of consolidation Cycle 1; and Days 1 and 5 of maintenance Cycle 1 (1 cycle is 28 days)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1; and Days 1 and 5 of consolidation Cycle 1 (1 cycle is 28 days)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and at predefined intervals post-dose on Days 1, 3, and 5 of induction Cycle 1 (1 cycle is 28 days)Population: Due to the insufficient enrollment of the planned Analysis Population, the planned outcome measurements were not conducted and result data were not collected.
The sponsor decided not to continue the study based on the overall Company strategy in AML. Although data were collected, the small sample size and insufficient follow up rendered any analysis scientifically meaningless. As a consequence, no data were analyzed and this outcome measure was not conducted
Outcome measures
Outcome data not reported
Adverse Events
DOSE ESCALATION COHORT 1
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
Dose Escalation Cohort 2
Serious events: 4 serious events
Other events: 9 other events
Deaths: 1 deaths
Dose Escalation Cohort 3
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
POST CONSOLIDATION PHASE COHORT
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
DOSE ESCALATION COHORT 1
n=4 participants at risk
For induction, participants will be treated with idasanutlin plus cytarabine and daunorubicin. At the investigator's discretion for consolidation, either participants will be treated with idasanutlin and cytarabine or they will undergo Allo-HSCT. For maintenance, participants will be treated with single-agent idasanutlin of 200 mg
|
Dose Escalation Cohort 2
n=9 participants at risk
350 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
|
Dose Escalation Cohort 3
n=6 participants at risk
250 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
|
POST CONSOLIDATION PHASE COHORT
n=4 participants at risk
Participants who are idasanutlin treatment-naive, had received induction and chemotherapy consolidation for AML outside of the study, and were in minimal residual disease (MRD)-positive remission after induction will be enrolled in this cohort to receive maintenance treatment with single-agent idasanutlin of 150 mg
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
50.0%
2/4 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
22.2%
2/9 • Number of events 5 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Infections and infestations
Metapneumovirus infection
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Infections and infestations
Sepsis
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
Other adverse events
| Measure |
DOSE ESCALATION COHORT 1
n=4 participants at risk
For induction, participants will be treated with idasanutlin plus cytarabine and daunorubicin. At the investigator's discretion for consolidation, either participants will be treated with idasanutlin and cytarabine or they will undergo Allo-HSCT. For maintenance, participants will be treated with single-agent idasanutlin of 200 mg
|
Dose Escalation Cohort 2
n=9 participants at risk
350 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
|
Dose Escalation Cohort 3
n=6 participants at risk
250 mg idasanutlin day 1 to day 5 in combination with cytarabine 200mg day 1 to day 7 and daunorubicin 60mg day 1 to day 3 in induction
|
POST CONSOLIDATION PHASE COHORT
n=4 participants at risk
Participants who are idasanutlin treatment-naive, had received induction and chemotherapy consolidation for AML outside of the study, and were in minimal residual disease (MRD)-positive remission after induction will be enrolled in this cohort to receive maintenance treatment with single-agent idasanutlin of 150 mg
|
|---|---|---|---|---|
|
Infections and infestations
Enterocolitis bacterial
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Infections and infestations
Conjunctivitis
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Infections and infestations
Cystitis
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Infections and infestations
Endophthalmitis
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
2/4 • Number of events 5 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
44.4%
4/9 • Number of events 5 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
2/6 • Number of events 4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
25.0%
1/4 • Number of events 10 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Blood and lymphatic system disorders
Coagulopathy
|
50.0%
2/4 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
75.0%
3/4 • Number of events 4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
88.9%
8/9 • Number of events 11 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
66.7%
4/6 • Number of events 4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Blood and lymphatic system disorders
Leukopenia
|
50.0%
2/4 • Number of events 7 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
75.0%
3/4 • Number of events 14 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
50.0%
2/4 • Number of events 17 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
50.0%
2/4 • Number of events 8 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
44.4%
4/9 • Number of events 5 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
50.0%
3/6 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
100.0%
4/4 • Number of events 9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Cardiac disorders
Atrial fibrillation
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Cardiac disorders
Pericarditis
|
25.0%
1/4 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Ear and labyrinth disorders
Ear swelling
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Eye disorders
Dry eye
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
3/9 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Eye disorders
Eye swelling
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
22.2%
2/9 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Eye disorders
Papilloedema
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
50.0%
3/6 • Number of events 4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Eye disorders
Retinal haemorrhage
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
2/6 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
2/4 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
44.4%
4/9 • Number of events 4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
2/6 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
50.0%
2/4 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
3/9 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
3/9 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
2/6 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
50.0%
2/4 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
4/4 • Number of events 6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
100.0%
9/9 • Number of events 14 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
83.3%
5/6 • Number of events 9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
75.0%
3/4 • Number of events 5 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Dyspepsia
|
75.0%
3/4 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
22.2%
2/9 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
2/6 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
2/6 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
22.2%
2/9 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
22.2%
2/9 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
88.9%
8/9 • Number of events 11 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
66.7%
4/6 • Number of events 5 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
100.0%
4/4 • Number of events 6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Oesophageal pain
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Oesophagitis haemorrhagic
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Oral pain
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Proctalgia
|
50.0%
2/4 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Stomatitis
|
50.0%
2/4 • Number of events 5 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
22.2%
2/9 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
50.0%
3/6 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Toothache
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4 • Number of events 4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
44.4%
4/9 • Number of events 5 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
50.0%
3/6 • Number of events 4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
50.0%
2/4 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
General disorders
Asthenia
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
50.0%
2/4 • Number of events 5 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
General disorders
Catheter site erythema
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
General disorders
Catheter site pain
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
General disorders
Catheter site rash
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
General disorders
Chest discomfort
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
General disorders
Chest pain
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
22.2%
2/9 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
General disorders
Chills
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
General disorders
Face oedema
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
22.2%
2/9 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
3/9 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
50.0%
3/6 • Number of events 4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
General disorders
Generalised oedema
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
22.2%
2/9 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
2/6 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
General disorders
Malaise
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
50.0%
2/4 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
General disorders
Mucosal inflammation
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
66.7%
6/9 • Number of events 6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
General disorders
Oedema peripheral
|
50.0%
2/4 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
3/9 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
83.3%
5/6 • Number of events 7 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
General disorders
Pain
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
22.2%
2/9 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
General disorders
Physical deconditioning
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
General disorders
Xerosis
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Infections and infestations
Bacillus bacteraemia
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
3/9 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Infections and infestations
Bacteroides bacteraemia
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Infections and infestations
COVID-19
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Infections and infestations
Candida infection
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
50.0%
3/6 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Infections and infestations
Influenza
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
3/9 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Infections and infestations
Paronychia
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Infections and infestations
Respiratory tract infection
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
22.2%
2/9 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
2/6 • Number of events 5 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Injury, poisoning and procedural complications
Scrotal injury
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
22.2%
2/9 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
66.7%
4/6 • Number of events 9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
66.7%
4/6 • Number of events 5 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
2/6 • Number of events 4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Investigations
Blood count abnormal
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Investigations
Blood uric acid decreased
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Investigations
Ejection fraction decreased
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Investigations
International normalised ratio increased
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
50.0%
3/6 • Number of events 5 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
2/6 • Number of events 8 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
2/6 • Number of events 4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
25.0%
1/4 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
2/6 • Number of events 4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Investigations
Weight decreased
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
2/6 • Number of events 5 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
2/4 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
22.2%
2/9 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
25.0%
1/4 • Number of events 4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Metabolism and nutrition disorders
Fluid overload
|
50.0%
2/4 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
22.2%
2/9 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
2/6 • Number of events 15 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
50.0%
3/6 • Number of events 7 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
2/6 • Number of events 8 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
3/9 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
66.7%
4/6 • Number of events 11 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
66.7%
4/6 • Number of events 6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
3/9 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
50.0%
3/6 • Number of events 5 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
22.2%
2/9 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Nervous system disorders
Ageusia
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
25.0%
1/4 • Number of events 4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Nervous system disorders
Dizziness postural
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Nervous system disorders
Dysgeusia
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
44.4%
4/9 • Number of events 4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
50.0%
3/6 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
22.2%
2/9 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Psychiatric disorders
Agitation
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Psychiatric disorders
Anxiety
|
50.0%
2/4 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Psychiatric disorders
Depression
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Psychiatric disorders
Insomnia
|
50.0%
2/4 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
50.0%
3/6 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Renal and urinary disorders
Acute kidney injury
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
2/6 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
22.2%
2/9 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
2/6 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
50.0%
2/4 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
22.2%
2/9 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
2/6 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
50.0%
2/4 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
22.2%
2/9 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
22.2%
2/9 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
50.0%
3/6 • Number of events 4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Leukoplakia
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
2/6 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
50.0%
2/4 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
3/9 • Number of events 5 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
66.7%
4/6 • Number of events 5 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
22.2%
2/9 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
22.2%
2/9 • Number of events 3 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
66.7%
4/6 • Number of events 4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
25.0%
1/4 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
22.2%
2/9 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
33.3%
2/6 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Toxic erythema of chemotherapy
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Transient acantholytic dermatosis
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Vascular disorders
Deep vein thrombosis
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Vascular disorders
Embolism
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/9 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
16.7%
1/6 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
22.2%
2/9 • Number of events 2 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
50.0%
3/6 • Number of events 5 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
11.1%
1/9 • Number of events 1 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/6 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
0.00%
0/4 • From baseline up to 28 days after the last study treatment depending on the stage of the study. The study was prematurely terminated. The last participant's last treatment was at Induction Cycle 1 Day 7.
Treatment and SFU
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER