Trial Outcomes & Findings for OXEL: Immune Checkpoint or Capecitabine or Combination Therapy as Adjuvant Therapy for TNBC With Residual Disease (NCT NCT03487666)
NCT ID: NCT03487666
Last Updated: 2024-12-03
Results Overview
PIS were developed using methods previously described (Farsaci, B. et al. Cancer Immunol. Res. 2016), based on tertile distribution of frequencies and ratios of peripheral immune cell subsets in patients prior to therapy. Immune subsets were calculated as a % of PBMC and sorted by frequency. Points were assigned to each subset in a given patient based on tertile distribution. For subsets with an expected positive effect on anti-tumor immunity zero (0) points were assigned to the low bin, one (1) point for the middle bin, and two (2) points if in the high bin. For subsets with an expected negative effect on anti-tumor immunity zero (0) points were assigned to the high bin, one (1) point for the middle bin, and two (2) points if in the low bin. The peripheral immunoscore for a given patient was the sum of points assigned to the individual PBMC subsets that were included within the immunoscore. Positive change means enhanced and negative change means reduced immune function.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
6 weeks
Results posted on
2024-12-03
Participant Flow
Participant milestones
| Measure |
Nivolumab (Arm A)
Nivolumab 360 mg iv q3weeks for x 6 cycles
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1) antibody currently approved in different diseases.
|
Capecitabine (Arm B)
Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
Capecitabine: Capecitabine was selected for Arm B given the recent results from CREATE-X trial and the increasing use by the community (feasibility). Importantly, available data from other scenarios indicates that capecitabine does not have immunosuppressive effects
|
Nivolumab + Capecitabine (Arm C)
Nivolumab 360mg iv q3weeks + Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1) antibody currently approved in different diseases.
Capecitabine: Capecitabine was selected for Arm B given the recent results from CREATE-X trial and the increasing use by the community (feasibility). Importantly, available data from other scenarios indicates that capecitabine does not have immunosuppressive effects
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
11
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
1
|
Reasons for withdrawal
| Measure |
Nivolumab (Arm A)
Nivolumab 360 mg iv q3weeks for x 6 cycles
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1) antibody currently approved in different diseases.
|
Capecitabine (Arm B)
Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
Capecitabine: Capecitabine was selected for Arm B given the recent results from CREATE-X trial and the increasing use by the community (feasibility). Importantly, available data from other scenarios indicates that capecitabine does not have immunosuppressive effects
|
Nivolumab + Capecitabine (Arm C)
Nivolumab 360mg iv q3weeks + Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1) antibody currently approved in different diseases.
Capecitabine: Capecitabine was selected for Arm B given the recent results from CREATE-X trial and the increasing use by the community (feasibility). Importantly, available data from other scenarios indicates that capecitabine does not have immunosuppressive effects
|
|---|---|---|---|
|
Overall Study
Disease progression
|
4
|
2
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
Baseline Characteristics
OXEL: Immune Checkpoint or Capecitabine or Combination Therapy as Adjuvant Therapy for TNBC With Residual Disease
Baseline characteristics by cohort
| Measure |
Arm A- Nivolumab
n=15 Participants
Nivolumab 360 mg iv q3weeks for x 6 cycles
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1) antibody currently approved in different diseases.
|
Arm B- Capecitabine
n=15 Participants
Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
Capecitabine: Capecitabine was selected for Arm B given the recent results from CREATE-X trial and the increasing use by the community (feasibility). Importantly, available data from other scenarios indicates that capecitabine does not have immunosuppressive effects
|
Arm C Nivolumab + Capecitabine
n=15 Participants
Nivolumab 360mg iv q3weeks + Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1) antibody currently approved in different diseases.
Capecitabine: Capecitabine was selected for Arm B given the recent results from CREATE-X trial and the increasing use by the community (feasibility). Importantly, available data from other scenarios indicates that capecitabine does not have immunosuppressive effects
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPIS were developed using methods previously described (Farsaci, B. et al. Cancer Immunol. Res. 2016), based on tertile distribution of frequencies and ratios of peripheral immune cell subsets in patients prior to therapy. Immune subsets were calculated as a % of PBMC and sorted by frequency. Points were assigned to each subset in a given patient based on tertile distribution. For subsets with an expected positive effect on anti-tumor immunity zero (0) points were assigned to the low bin, one (1) point for the middle bin, and two (2) points if in the high bin. For subsets with an expected negative effect on anti-tumor immunity zero (0) points were assigned to the high bin, one (1) point for the middle bin, and two (2) points if in the low bin. The peripheral immunoscore for a given patient was the sum of points assigned to the individual PBMC subsets that were included within the immunoscore. Positive change means enhanced and negative change means reduced immune function.
Outcome measures
| Measure |
Arm A- Nivolumab
n=15 Participants
Nivolumab 360 mg iv q3weeks for x 6 cycles
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1) antibody currently approved in different diseases.
|
Arm B- Capecitabine
n=14 Participants
Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
Capecitabine: Capecitabine was selected for Arm B given the recent results from CREATE-X trial and the increasing use by the community (feasibility). Importantly, available data from other scenarios indicates that capecitabine does not have immunosuppressive effects
|
Arm C Nivolumab + Capecitabine
n=13 Participants
Nivolumab 360mg iv q3weeks + Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1) antibody currently approved in different diseases.
Capecitabine: Capecitabine was selected for Arm B given the recent results from CREATE-X trial and the increasing use by the community (feasibility). Importantly, available data from other scenarios indicates that capecitabine does not have immunosuppressive effects
|
|---|---|---|---|
|
Percent Change in the Peripheral Immunoscore (PIS) at Week 6
|
30.63 % Change in PIS
Interval -37.5 to 175.0
|
-21.9 % Change in PIS
Interval -55.56 to 14.286
|
32.285 % Change in PIS
Interval -57.143 to 300.0
|
SECONDARY outcome
Timeframe: 12 weeksPISs were developed using methods previously described (Farsaci, B. et al. Cancer Immunol. Res. 2016), based on tertile distribution of frequencies and ratios of peripheral immune cell subsets in patients prior to therapy. Immune subsets were calculated as a % of PBMC and sorted by frequency. Points were assigned to each subset in a given patient based on tertile distribution. For subsets with an expected positive effect on anti-tumor immunity zero (0) points were assigned to the low bin, one (1) point for the middle bin, and two (2) points if in the high bin. For subsets with an expected negative effect on anti-tumor immunity zero (0) points were assigned to the high bin, one (1) point for the middle bin, and two (2) points if in the low bin. The peripheral immunoscore for a given patient was the sum of points assigned to the individual PBMC subsets that were included within the immunoscore. Positivie change mean enhanced and negative change means reduced immune function.
Outcome measures
| Measure |
Arm A- Nivolumab
n=15 Participants
Nivolumab 360 mg iv q3weeks for x 6 cycles
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1) antibody currently approved in different diseases.
|
Arm B- Capecitabine
n=12 Participants
Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
Capecitabine: Capecitabine was selected for Arm B given the recent results from CREATE-X trial and the increasing use by the community (feasibility). Importantly, available data from other scenarios indicates that capecitabine does not have immunosuppressive effects
|
Arm C Nivolumab + Capecitabine
n=12 Participants
Nivolumab 360mg iv q3weeks + Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1) antibody currently approved in different diseases.
Capecitabine: Capecitabine was selected for Arm B given the recent results from CREATE-X trial and the increasing use by the community (feasibility). Importantly, available data from other scenarios indicates that capecitabine does not have immunosuppressive effects
|
|---|---|---|---|
|
Percent Change of Peripheral Immuno Score (PIS) at Week 12
|
33.3 % Change in PIS
Interval -37.5 to 175.0
|
-16.2 % Change in PIS
Interval -55.6 to 50.0
|
18.83 % Change in PIS
Interval -62.5 to 275.0
|
SECONDARY outcome
Timeframe: From date of consent until 100 days after the last dose of study treatment, approximately up to 11 monthsThe number of grade 3 and 4 adverse events as assessed clinically by an investigator, according to the National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0 \[NCI CTCAE v4.03\]. Grade 4 adverse events were associated with worse outcomes.
Outcome measures
| Measure |
Arm A- Nivolumab
n=14 Participants
Nivolumab 360 mg iv q3weeks for x 6 cycles
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1) antibody currently approved in different diseases.
|
Arm B- Capecitabine
n=15 Participants
Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
Capecitabine: Capecitabine was selected for Arm B given the recent results from CREATE-X trial and the increasing use by the community (feasibility). Importantly, available data from other scenarios indicates that capecitabine does not have immunosuppressive effects
|
Arm C Nivolumab + Capecitabine
n=15 Participants
Nivolumab 360mg iv q3weeks + Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1) antibody currently approved in different diseases.
Capecitabine: Capecitabine was selected for Arm B given the recent results from CREATE-X trial and the increasing use by the community (feasibility). Importantly, available data from other scenarios indicates that capecitabine does not have immunosuppressive effects
|
|---|---|---|---|
|
Grade 3 and 4 Adverse Events
Grade 3 Adverse Events
|
2 number of adverse events
|
8 number of adverse events
|
3 number of adverse events
|
|
Grade 3 and 4 Adverse Events
Grade 4 Adverse Events
|
0 number of adverse events
|
0 number of adverse events
|
0 number of adverse events
|
SECONDARY outcome
Timeframe: 2 yearsiDFS was defined as the time from date of randomization to the date of first invasive disease recurrence, second invasive primary cancer (breast or not), or death from any cause.
Outcome measures
| Measure |
Arm A- Nivolumab
n=15 Participants
Nivolumab 360 mg iv q3weeks for x 6 cycles
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1) antibody currently approved in different diseases.
|
Arm B- Capecitabine
n=15 Participants
Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
Capecitabine: Capecitabine was selected for Arm B given the recent results from CREATE-X trial and the increasing use by the community (feasibility). Importantly, available data from other scenarios indicates that capecitabine does not have immunosuppressive effects
|
Arm C Nivolumab + Capecitabine
n=15 Participants
Nivolumab 360mg iv q3weeks + Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1) antibody currently approved in different diseases.
Capecitabine: Capecitabine was selected for Arm B given the recent results from CREATE-X trial and the increasing use by the community (feasibility). Importantly, available data from other scenarios indicates that capecitabine does not have immunosuppressive effects
|
|---|---|---|---|
|
Invasive Disease Free Survival (DRFS)
|
16.75 Months
Interval 3.05 to 41.18
|
16.04 Months
Interval 0.52 to 37.05
|
21.37 Months
Interval 7.31 to 35.41
|
SECONDARY outcome
Timeframe: 6 weeks and 12 weeksPopulation: The number analyzed reflects those patients that had samples that were analyzed.
Out of the patients with available ct-DNA samples at baseline, week 6 and week 12, the proportion of patients with detectable ct-DNA at the same timepoints.
Outcome measures
| Measure |
Arm A- Nivolumab
n=13 Participants
Nivolumab 360 mg iv q3weeks for x 6 cycles
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1) antibody currently approved in different diseases.
|
Arm B- Capecitabine
n=12 Participants
Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
Capecitabine: Capecitabine was selected for Arm B given the recent results from CREATE-X trial and the increasing use by the community (feasibility). Importantly, available data from other scenarios indicates that capecitabine does not have immunosuppressive effects
|
Arm C Nivolumab + Capecitabine
n=13 Participants
Nivolumab 360mg iv q3weeks + Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1) antibody currently approved in different diseases.
Capecitabine: Capecitabine was selected for Arm B given the recent results from CREATE-X trial and the increasing use by the community (feasibility). Importantly, available data from other scenarios indicates that capecitabine does not have immunosuppressive effects
|
|---|---|---|---|
|
Circulating Tumor DNA
Baseline
|
6 Participants
|
4 Participants
|
4 Participants
|
|
Circulating Tumor DNA
Week 6
|
6 Participants
|
2 Participants
|
1 Participants
|
|
Circulating Tumor DNA
Week 12
|
6 Participants
|
3 Participants
|
1 Participants
|
Adverse Events
Arm A- Nivolumab
Serious events: 3 serious events
Other events: 14 other events
Deaths: 5 deaths
Arm B- Capecitabine
Serious events: 0 serious events
Other events: 15 other events
Deaths: 2 deaths
Arm C Nivolumab + Capecitabine
Serious events: 3 serious events
Other events: 15 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm A- Nivolumab
n=15 participants at risk
Nivolumab 360 mg iv q3weeks for x 6 cycles
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1) antibody currently approved in different diseases.
|
Arm B- Capecitabine
n=15 participants at risk
Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
Capecitabine: Capecitabine was selected for Arm B given the recent results from CREATE-X trial and the increasing use by the community (feasibility). Importantly, available data from other scenarios indicates that capecitabine does not have immunosuppressive effects
|
Arm C Nivolumab + Capecitabine
n=15 participants at risk
Nivolumab 360mg iv q3weeks + Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1) antibody currently approved in different diseases.
Capecitabine: Capecitabine was selected for Arm B given the recent results from CREATE-X trial and the increasing use by the community (feasibility). Importantly, available data from other scenarios indicates that capecitabine does not have immunosuppressive effects
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Infections and infestations
Breast infection
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
Other adverse events
| Measure |
Arm A- Nivolumab
n=15 participants at risk
Nivolumab 360 mg iv q3weeks for x 6 cycles
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1) antibody currently approved in different diseases.
|
Arm B- Capecitabine
n=15 participants at risk
Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
Capecitabine: Capecitabine was selected for Arm B given the recent results from CREATE-X trial and the increasing use by the community (feasibility). Importantly, available data from other scenarios indicates that capecitabine does not have immunosuppressive effects
|
Arm C Nivolumab + Capecitabine
n=15 participants at risk
Nivolumab 360mg iv q3weeks + Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
Nivolumab: Nivolumab is a human programmed death receptor-1 (PD-1) antibody currently approved in different diseases.
Capecitabine: Capecitabine was selected for Arm B given the recent results from CREATE-X trial and the increasing use by the community (feasibility). Importantly, available data from other scenarios indicates that capecitabine does not have immunosuppressive effects
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Infections and infestations
Urinary tract infection
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
13.3%
2/15 • Number of events 2 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
13.3%
2/15 • Number of events 3 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
3/15 • Number of events 4 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
26.7%
4/15 • Number of events 5 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Cardiac disorders
Sinus tachycardia
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Endocrine disorders
Hyperthyroidism
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Eye disorders
Blurred vision
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Eye disorders
Dry Eye
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Eye disorders
Watering eyes
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
13.3%
2/15 • Number of events 2 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
20.0%
3/15 • Number of events 3 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
3/15 • Number of events 3 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
53.3%
8/15 • Number of events 16 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
46.7%
7/15 • Number of events 17 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 2 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
46.7%
7/15 • Number of events 14 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
73.3%
11/15 • Number of events 18 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
20.0%
3/15 • Number of events 8 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
20.0%
3/15 • Number of events 3 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
33.3%
5/15 • Number of events 6 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
20.0%
3/15 • Number of events 3 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
General disorders
Chills
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
General disorders
Edema limbs
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 2 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
General disorders
Fatigue
|
46.7%
7/15 • Number of events 11 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
33.3%
5/15 • Number of events 6 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
46.7%
7/15 • Number of events 12 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
13.3%
2/15 • Number of events 3 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 2 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
20.0%
3/15 • Number of events 4 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Investigations
Aspartate aminotransferase increased
|
13.3%
2/15 • Number of events 3 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
13.3%
2/15 • Number of events 2 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
20.0%
3/15 • Number of events 4 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Investigations
Lymphocyte count decreased
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Investigations
Neutrophil count decreased
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Investigations
Platelet count decreased
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Investigations
Weight gain
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
5/15 • Number of events 5 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 2 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 8 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
13.3%
2/15 • Number of events 2 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 2 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • Number of events 2 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
13.3%
2/15 • Number of events 2 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
13.3%
2/15 • Number of events 3 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Nervous system disorders
Paresthesia
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
26.7%
4/15 • Number of events 6 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
26.7%
4/15 • Number of events 4 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Psychiatric disorders
Anxiety
|
13.3%
2/15 • Number of events 3 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
13.3%
2/15 • Number of events 2 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Psychiatric disorders
Depression
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
13.3%
2/15 • Number of events 2 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
20.0%
3/15 • Number of events 3 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Reproductive system and breast disorders
Breast pain
|
13.3%
2/15 • Number of events 2 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
13.3%
2/15 • Number of events 2 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
2/15 • Number of events 2 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 2 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 2 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
26.7%
4/15 • Number of events 4 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
13.3%
2/15 • Number of events 4 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Vascular disorders
Hypertension
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/15 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
6.7%
1/15 • Number of events 1 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
20.0%
3/15 • Number of events 3 • Adverse events and serious adverse events collected from date of consent until 100 days after the last dose of study treatment, approximately up to 11 months. All cause mortality collected for up to 3 years after study drug discontinuation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place