Trial Outcomes & Findings for Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Breast Cancer (NCT NCT03839823)
NCT ID: NCT03839823
Last Updated: 2024-10-09
Results Overview
Progression-free survival was defined as the time from the date of randomization to the date of the first documented progression as per local review and according to RECIST 1.1 or death due to any cause. PFS was censored at the date of the last adequate tumor assessment if no PFS event was observed at the time of last patient, last visit (LPLV).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
222 participants
Primary outcome timeframe
Up to approximately 34 months
Results posted on
2024-10-09
Participant Flow
Participant milestones
| Measure |
Ribociclib 600 mg
Combination of non-steroidal aromatase inhibitor: NSAI (letrozole or anastrozole) + goserelin + ribociclib.
1. Ribociclib (600 mg) was dosed orally for the first 21 days out of a 28-day cycle.
2. Letrozole (2.5 mg) or anastrozole (1 mg) were dosed orally daily (28 days out of the 28-day cycle).
3. Goserelin (3.6 mg) was continuously released via a subcutaneous implant injected on Day 1 of each 28-day cycle (regardless of ribociclib treatment cycle) with an administration window of + 3 days.
|
Combination Chemotherapy
Combination chemotherapies of docetaxel/capecitabine, paclitaxel/gemcitabine or capecitabine/vinorelbine were administered to patients enrolled in the control group. The chemotherapy regimen was decided by the treating physician.
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
110
|
|
Overall Study
Treated
|
112
|
100
|
|
Overall Study
Not Treated
|
0
|
10
|
|
Overall Study
COMPLETED
|
35
|
17
|
|
Overall Study
NOT COMPLETED
|
77
|
93
|
Reasons for withdrawal
| Measure |
Ribociclib 600 mg
Combination of non-steroidal aromatase inhibitor: NSAI (letrozole or anastrozole) + goserelin + ribociclib.
1. Ribociclib (600 mg) was dosed orally for the first 21 days out of a 28-day cycle.
2. Letrozole (2.5 mg) or anastrozole (1 mg) were dosed orally daily (28 days out of the 28-day cycle).
3. Goserelin (3.6 mg) was continuously released via a subcutaneous implant injected on Day 1 of each 28-day cycle (regardless of ribociclib treatment cycle) with an administration window of + 3 days.
|
Combination Chemotherapy
Combination chemotherapies of docetaxel/capecitabine, paclitaxel/gemcitabine or capecitabine/vinorelbine were administered to patients enrolled in the control group. The chemotherapy regimen was decided by the treating physician.
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
4
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
5
|
|
Overall Study
Progressive Disease (PD)
|
65
|
65
|
|
Overall Study
Subject Decision
|
2
|
9
|
|
Overall Study
Not Treated
|
0
|
10
|
Baseline Characteristics
Data are reported for participants in the full analysis set who had available data.
Baseline characteristics by cohort
| Measure |
Ribociclib 600 mg
n=112 Participants
Combination of non-steroidal aromatase inhibitor: NSAI (letrozole or anastrozole) + goserelin + ribociclib.
1. Ribociclib (600 mg) was dosed orally for the first 21 days out of a 28-day cycle.
2. Letrozole (2.5 mg) or anastrozole (1 mg) were dosed orally daily (28 days out of the 28-day cycle).
3. Goserelin (3.6 mg) was continuously released via a subcutaneous implant injected on Day 1 of each 28-day cycle (regardless of ribociclib treatment cycle) with an administration window of + 3 days.
|
Combination Chemotherapy
n=110 Participants
Combination chemotherapies of docetaxel/capecitabine, paclitaxel/gemcitabine or capecitabine/vinorelbine were administered to patients enrolled in the control group. The chemotherapy regimen was decided by the treating physician.
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.9 years
STANDARD_DEVIATION 6.26 • n=112 Participants
|
42.0 years
STANDARD_DEVIATION 6.72 • n=110 Participants
|
42.5 years
STANDARD_DEVIATION 6.49 • n=222 Participants
|
|
Sex/Gender, Customized
Female
|
112 participants
n=112 Participants
|
110 participants
n=110 Participants
|
222 participants
n=222 Participants
|
|
Race/Ethnicity, Customized
Asian
|
60 participants
n=112 Participants
|
58 participants
n=110 Participants
|
118 participants
n=222 Participants
|
|
Race/Ethnicity, Customized
White
|
51 participants
n=112 Participants
|
52 participants
n=110 Participants
|
103 participants
n=222 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=112 Participants
|
0 participants
n=110 Participants
|
1 participants
n=222 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
108 participants
n=112 Participants
|
108 participants
n=110 Participants
|
216 participants
n=222 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
3 participants
n=112 Participants
|
1 participants
n=110 Participants
|
4 participants
n=222 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 participants
n=112 Participants
|
1 participants
n=110 Participants
|
2 participants
n=222 Participants
|
|
Height
|
157.50 cm
STANDARD_DEVIATION 7.489 • n=111 Participants • Data are reported for participants in the full analysis set who had available data.
|
158.34 cm
STANDARD_DEVIATION 6.548 • n=109 Participants • Data are reported for participants in the full analysis set who had available data.
|
157.92 cm
STANDARD_DEVIATION 7.035 • n=220 Participants • Data are reported for participants in the full analysis set who had available data.
|
PRIMARY outcome
Timeframe: Up to approximately 34 monthsPopulation: The full analysis set comprised all patients to whom study treatment was assigned by randomization.
Progression-free survival was defined as the time from the date of randomization to the date of the first documented progression as per local review and according to RECIST 1.1 or death due to any cause. PFS was censored at the date of the last adequate tumor assessment if no PFS event was observed at the time of last patient, last visit (LPLV).
Outcome measures
| Measure |
Ribociclib 600 mg
n=112 Participants
Combination of non-steroidal aromatase inhibitor: NSAI (letrozole or anastrozole) + goserelin + ribociclib.
1. Ribociclib (600 mg) was dosed orally for the first 21 days out of a 28-day cycle.
2. Letrozole (2.5 mg) or anastrozole (1 mg) were dosed orally daily (28 days out of the 28-day cycle).
3. Goserelin (3.6 mg) was continuously released via a subcutaneous implant injected on Day 1 of each 28-day cycle (regardless of ribociclib treatment cycle) with an administration window of + 3 days.
|
Combination Chemotherapy
n=110 Participants
Combination chemotherapies of docetaxel/capecitabine, paclitaxel/gemcitabine or capecitabine/vinorelbine were administered to patients enrolled in the control group. The chemotherapy regimen was decided by the treating physician.
|
|---|---|---|
|
Progression-free Survival
|
21.8 months
Interval 17.4 to 26.7
|
12.8 months
Interval 10.1 to 18.4
|
SECONDARY outcome
Timeframe: Up to approximately 34 monthsPopulation: The full analysis set comprised all patients to whom study treatment was assigned by randomization.
Time to treatment failure was defined as the time from the date of randomization/start of treatment to the earliest of date of progression, date of death due to any cause, change to other anti-cancer therapy, or date of discontinuation due to reasons other than 'Protocol violation' or 'Administrative problems'. Patients who did not achieve a confirmed PR or CR were censored at: the maximum follow-up time (i.e., LPLV - first patient first visit \[FPFV\] used for the analysis) for patients who had a PFS event (i.e., either progressed or died due to any cause); the last adequate tumor assessment date for all other patients.
Outcome measures
| Measure |
Ribociclib 600 mg
n=112 Participants
Combination of non-steroidal aromatase inhibitor: NSAI (letrozole or anastrozole) + goserelin + ribociclib.
1. Ribociclib (600 mg) was dosed orally for the first 21 days out of a 28-day cycle.
2. Letrozole (2.5 mg) or anastrozole (1 mg) were dosed orally daily (28 days out of the 28-day cycle).
3. Goserelin (3.6 mg) was continuously released via a subcutaneous implant injected on Day 1 of each 28-day cycle (regardless of ribociclib treatment cycle) with an administration window of + 3 days.
|
Combination Chemotherapy
n=110 Participants
Combination chemotherapies of docetaxel/capecitabine, paclitaxel/gemcitabine or capecitabine/vinorelbine were administered to patients enrolled in the control group. The chemotherapy regimen was decided by the treating physician.
|
|---|---|---|
|
Time to Treatment Failure
|
18.6 months
Interval 13.2 to 24.0
|
9.1 months
Interval 7.6 to 12.3
|
SECONDARY outcome
Timeframe: Up to approximately 3 monthsPopulation: The full analysis set comprised all patients to whom study treatment was assigned by randomization.
Treatment failure rate was defined as the percentage of patients who discontinued the study treatment due to progressive disease, death due to any cause, change to other anti-cancer therapy, or discontinuation due to reasons other than protocol violation or administrative problems.
Outcome measures
| Measure |
Ribociclib 600 mg
n=112 Participants
Combination of non-steroidal aromatase inhibitor: NSAI (letrozole or anastrozole) + goserelin + ribociclib.
1. Ribociclib (600 mg) was dosed orally for the first 21 days out of a 28-day cycle.
2. Letrozole (2.5 mg) or anastrozole (1 mg) were dosed orally daily (28 days out of the 28-day cycle).
3. Goserelin (3.6 mg) was continuously released via a subcutaneous implant injected on Day 1 of each 28-day cycle (regardless of ribociclib treatment cycle) with an administration window of + 3 days.
|
Combination Chemotherapy
n=110 Participants
Combination chemotherapies of docetaxel/capecitabine, paclitaxel/gemcitabine or capecitabine/vinorelbine were administered to patients enrolled in the control group. The chemotherapy regimen was decided by the treating physician.
|
|---|---|---|
|
3-month Treatment Failure Rate
|
11.6 percentage of participants
Interval 6.3 to 19.0
|
21.8 percentage of participants
Interval 14.5 to 30.7
|
SECONDARY outcome
Timeframe: Up to approximately 34 monthsPopulation: The full analysis set comprised all patients to whom study treatment was assigned by randomization.
Overall response rate (ORR) was defined as the percentage of patients with a best overall response (BOR) of complete response (CR) or partial response (PR, response without image confirmation), as per local review and according to RECIST 1.1.
Outcome measures
| Measure |
Ribociclib 600 mg
n=112 Participants
Combination of non-steroidal aromatase inhibitor: NSAI (letrozole or anastrozole) + goserelin + ribociclib.
1. Ribociclib (600 mg) was dosed orally for the first 21 days out of a 28-day cycle.
2. Letrozole (2.5 mg) or anastrozole (1 mg) were dosed orally daily (28 days out of the 28-day cycle).
3. Goserelin (3.6 mg) was continuously released via a subcutaneous implant injected on Day 1 of each 28-day cycle (regardless of ribociclib treatment cycle) with an administration window of + 3 days.
|
Combination Chemotherapy
n=110 Participants
Combination chemotherapies of docetaxel/capecitabine, paclitaxel/gemcitabine or capecitabine/vinorelbine were administered to patients enrolled in the control group. The chemotherapy regimen was decided by the treating physician.
|
|---|---|---|
|
Overall Response Rate (ORR)
|
66.1 percentage of participants
Interval 56.5 to 74.7
|
61.8 percentage of participants
Interval 52.1 to 70.9
|
SECONDARY outcome
Timeframe: Up to approximately 34 monthsPopulation: The full analysis set comprised all patients to whom study treatment was assigned by randomization.
Clinical benefit rate was defined as the percentage of patients with a BOR of CR, PR, or stable disease (SD, response without image confirmation) lasting 24 weeks or longer, as defined by RECIST 1.1.
Outcome measures
| Measure |
Ribociclib 600 mg
n=112 Participants
Combination of non-steroidal aromatase inhibitor: NSAI (letrozole or anastrozole) + goserelin + ribociclib.
1. Ribociclib (600 mg) was dosed orally for the first 21 days out of a 28-day cycle.
2. Letrozole (2.5 mg) or anastrozole (1 mg) were dosed orally daily (28 days out of the 28-day cycle).
3. Goserelin (3.6 mg) was continuously released via a subcutaneous implant injected on Day 1 of each 28-day cycle (regardless of ribociclib treatment cycle) with an administration window of + 3 days.
|
Combination Chemotherapy
n=110 Participants
Combination chemotherapies of docetaxel/capecitabine, paclitaxel/gemcitabine or capecitabine/vinorelbine were administered to patients enrolled in the control group. The chemotherapy regimen was decided by the treating physician.
|
|---|---|---|
|
Clinical Benefit Rate
|
81.3 percentage of participants
Interval 72.8 to 88.0
|
74.5 percentage of participants
Interval 65.4 to 82.4
|
SECONDARY outcome
Timeframe: Up to approximately 34 monthsPopulation: The full analysis set comprised all patients to whom study treatment was assigned by randomization.
Time to response was defined as the time from the date of randomization to the first documented response of either CR or PR, which must be subsequently confirmed, as defined by RECIST 1.1. Patients who did not achieve a confirmed PR or CR were censored at: the maximum follow-up time (i.e., LPLV - FPFV used for the analysis) for patients who had a PFS event (i.e., either progressed or died due to any cause); the last adequate tumor assessment date for all other patients.
Outcome measures
| Measure |
Ribociclib 600 mg
n=112 Participants
Combination of non-steroidal aromatase inhibitor: NSAI (letrozole or anastrozole) + goserelin + ribociclib.
1. Ribociclib (600 mg) was dosed orally for the first 21 days out of a 28-day cycle.
2. Letrozole (2.5 mg) or anastrozole (1 mg) were dosed orally daily (28 days out of the 28-day cycle).
3. Goserelin (3.6 mg) was continuously released via a subcutaneous implant injected on Day 1 of each 28-day cycle (regardless of ribociclib treatment cycle) with an administration window of + 3 days.
|
Combination Chemotherapy
n=110 Participants
Combination chemotherapies of docetaxel/capecitabine, paclitaxel/gemcitabine or capecitabine/vinorelbine were administered to patients enrolled in the control group. The chemotherapy regimen was decided by the treating physician.
|
|---|---|---|
|
Time to Response
|
4.9 months
Interval 4.5 to 8.3
|
3.2 months
Interval 2.7 to 4.7
|
SECONDARY outcome
Timeframe: Up to approximately 46 monthsPopulation: The full analysis set comprised all patients to whom study treatment was assigned by randomization.
Overall survival was defined as the time from the date of randomization to the date of death due to any cause. If a patient was not known to have died at the time of LPLV, then OS was censored at the last contact date.
Outcome measures
| Measure |
Ribociclib 600 mg
n=112 Participants
Combination of non-steroidal aromatase inhibitor: NSAI (letrozole or anastrozole) + goserelin + ribociclib.
1. Ribociclib (600 mg) was dosed orally for the first 21 days out of a 28-day cycle.
2. Letrozole (2.5 mg) or anastrozole (1 mg) were dosed orally daily (28 days out of the 28-day cycle).
3. Goserelin (3.6 mg) was continuously released via a subcutaneous implant injected on Day 1 of each 28-day cycle (regardless of ribociclib treatment cycle) with an administration window of + 3 days.
|
Combination Chemotherapy
n=110 Participants
Combination chemotherapies of docetaxel/capecitabine, paclitaxel/gemcitabine or capecitabine/vinorelbine were administered to patients enrolled in the control group. The chemotherapy regimen was decided by the treating physician.
|
|---|---|---|
|
Overall Survival (OS)
|
NA months
Interval 38.6 to
Median and the upper limit of 95% CI were not estimable due to an insufficient number of participants with events.
|
NA months
Interval 30.8 to
Median and the upper limit of 95% CI were not estimable due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to approximately 46 monthsPopulation: The full analysis set comprised all patients to whom study treatment was assigned by randomization. Results are reported for participants with data available at the specified timepoint.
FACT-B is a self-reported instrument that measures multidimensional quality of life (QOL) in patients with breast cancer. The FACT-B consists of 37 questions that address physical, social, emotional, and functional well-being, with specific questions relevant to women with breast cancer. Each item has a score range of 0 (Not at all) to 4 (Very much), with a total score ranging from 0-148. The higher the score, the better the QOL reported by the participant. A positive change from baseline indicates improvement in QoL.
Outcome measures
| Measure |
Ribociclib 600 mg
n=112 Participants
Combination of non-steroidal aromatase inhibitor: NSAI (letrozole or anastrozole) + goserelin + ribociclib.
1. Ribociclib (600 mg) was dosed orally for the first 21 days out of a 28-day cycle.
2. Letrozole (2.5 mg) or anastrozole (1 mg) were dosed orally daily (28 days out of the 28-day cycle).
3. Goserelin (3.6 mg) was continuously released via a subcutaneous implant injected on Day 1 of each 28-day cycle (regardless of ribociclib treatment cycle) with an administration window of + 3 days.
|
Combination Chemotherapy
n=110 Participants
Combination chemotherapies of docetaxel/capecitabine, paclitaxel/gemcitabine or capecitabine/vinorelbine were administered to patients enrolled in the control group. The chemotherapy regimen was decided by the treating physician.
|
|---|---|---|
|
Change From Baseline in the Global Health Status/Quality of Life (QOL) Scale Score by Using the Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire
Week 20 n=94,76
|
5.9 score on a scale
Standard Deviation 18.18
|
4.9 score on a scale
Standard Deviation 17.51
|
|
Change From Baseline in the Global Health Status/Quality of Life (QOL) Scale Score by Using the Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire
Week 28 n=87,67
|
7.9 score on a scale
Standard Deviation 17.54
|
6.2 score on a scale
Standard Deviation 16.15
|
|
Change From Baseline in the Global Health Status/Quality of Life (QOL) Scale Score by Using the Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire
Week 36 n=79,56
|
7.3 score on a scale
Standard Deviation 18.65
|
6.5 score on a scale
Standard Deviation 16.60
|
|
Change From Baseline in the Global Health Status/Quality of Life (QOL) Scale Score by Using the Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire
Week 44 n=75,50
|
7.2 score on a scale
Standard Deviation 18.33
|
6.6 score on a scale
Standard Deviation 14.39
|
|
Change From Baseline in the Global Health Status/Quality of Life (QOL) Scale Score by Using the Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire
Week 68 n=64,32
|
7.4 score on a scale
Standard Deviation 19.86
|
5.1 score on a scale
Standard Deviation 16.92
|
|
Change From Baseline in the Global Health Status/Quality of Life (QOL) Scale Score by Using the Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire
Week 80 n=53,22
|
7.1 score on a scale
Standard Deviation 25.49
|
7.0 score on a scale
Standard Deviation 14.50
|
|
Change From Baseline in the Global Health Status/Quality of Life (QOL) Scale Score by Using the Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire
Week 92 n=45,16
|
9.4 score on a scale
Standard Deviation 22.46
|
9.6 score on a scale
Standard Deviation 20.24
|
|
Change From Baseline in the Global Health Status/Quality of Life (QOL) Scale Score by Using the Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire
Week 104 n=36,12
|
7.9 score on a scale
Standard Deviation 22.26
|
15.1 score on a scale
Standard Deviation 13.04
|
|
Change From Baseline in the Global Health Status/Quality of Life (QOL) Scale Score by Using the Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire
Week 116 n=29,8
|
5.3 score on a scale
Standard Deviation 23.58
|
15.8 score on a scale
Standard Deviation 7.92
|
|
Change From Baseline in the Global Health Status/Quality of Life (QOL) Scale Score by Using the Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire
Week 128 n=26,8
|
2.8 score on a scale
Standard Deviation 24.17
|
17.0 score on a scale
Standard Deviation 11.40
|
|
Change From Baseline in the Global Health Status/Quality of Life (QOL) Scale Score by Using the Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire
Week 140 n=21,6
|
10.9 score on a scale
Standard Deviation 24.30
|
20.8 score on a scale
Standard Deviation 13.80
|
|
Change From Baseline in the Global Health Status/Quality of Life (QOL) Scale Score by Using the Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire
Week 152 n=17,5
|
3.6 score on a scale
Standard Deviation 20.39
|
17.0 score on a scale
Standard Deviation 14.06
|
|
Change From Baseline in the Global Health Status/Quality of Life (QOL) Scale Score by Using the Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire
Week 164 n=10,1
|
1.6 score on a scale
Standard Deviation 16.56
|
33.8 score on a scale
Standard Deviation NA
Due to a single participant at this timepoint, standard deviation was not applicable.
|
|
Change From Baseline in the Global Health Status/Quality of Life (QOL) Scale Score by Using the Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire
Week 176 n=3,1
|
16.9 score on a scale
Standard Deviation 31.39
|
39.7 score on a scale
Standard Deviation NA
Due to a single participant at this timepoint, standard deviation was not applicable.
|
|
Change From Baseline in the Global Health Status/Quality of Life (QOL) Scale Score by Using the Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire
Week 56 n=68,38
|
7.3 score on a scale
Standard Deviation 20.79
|
4.7 score on a scale
Standard Deviation 16.13
|
|
Change From Baseline in the Global Health Status/Quality of Life (QOL) Scale Score by Using the Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire
Week 188 n=1,0
|
7.0 score on a scale
Standard Deviation NA
Due to a single participant at this timepoint, standard deviation was not applicable.
|
—
|
|
Change From Baseline in the Global Health Status/Quality of Life (QOL) Scale Score by Using the Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire
Week 6 n=109,90
|
4.3 score on a scale
Standard Deviation 13.45
|
4.8 score on a scale
Standard Deviation 15.33
|
|
Change From Baseline in the Global Health Status/Quality of Life (QOL) Scale Score by Using the Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire
Week 12 n=100,82
|
5.5 score on a scale
Standard Deviation 16.28
|
4.4 score on a scale
Standard Deviation 16.73
|
SECONDARY outcome
Timeframe: Up to approximately 46 monthsPopulation: The safety set included all patients who received at least one dose of study treatment.
Adverse events were assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 or higher. If CTCAE grading did not exist for an adverse event, the severity of mild, moderate, severe, and life-threatening, corresponding to Grades 1 - 4, were used. A patient with multiple severity grades for an AE was only counted under the maximum grade. Data for Grades 3 and 4 are reported.
Outcome measures
| Measure |
Ribociclib 600 mg
n=112 Participants
Combination of non-steroidal aromatase inhibitor: NSAI (letrozole or anastrozole) + goserelin + ribociclib.
1. Ribociclib (600 mg) was dosed orally for the first 21 days out of a 28-day cycle.
2. Letrozole (2.5 mg) or anastrozole (1 mg) were dosed orally daily (28 days out of the 28-day cycle).
3. Goserelin (3.6 mg) was continuously released via a subcutaneous implant injected on Day 1 of each 28-day cycle (regardless of ribociclib treatment cycle) with an administration window of + 3 days.
|
Combination Chemotherapy
n=100 Participants
Combination chemotherapies of docetaxel/capecitabine, paclitaxel/gemcitabine or capecitabine/vinorelbine were administered to patients enrolled in the control group. The chemotherapy regimen was decided by the treating physician.
|
|---|---|---|
|
Number of Patients With Adverse Events, Categorized by Severity
Grade 4
|
18 Participants
|
11 Participants
|
|
Number of Patients With Adverse Events, Categorized by Severity
All grades
|
112 Participants
|
100 Participants
|
|
Number of Patients With Adverse Events, Categorized by Severity
Grade 3
|
71 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 46 monthsPopulation: The safety set included all patients who received at least one dose of study treatment.
Grading of laboratory values was assigned programmatically as per NCI Common Terminology Criteria for Adverse Events (CTCAE) version available at the time of analysis. The calculation of CTCAE grades was based on the observed laboratory values only, clinical assessments were not be taken into account. CTCAE Grade 0 was assigned for all non-missing values not graded as 1 or higher. Grade 5 was not used. For laboratory tests where grades were not defined by CTCAE available at the time of analysis, results were categorized as low/normal/high based on laboratory normal ranges.
Outcome measures
| Measure |
Ribociclib 600 mg
n=112 Participants
Combination of non-steroidal aromatase inhibitor: NSAI (letrozole or anastrozole) + goserelin + ribociclib.
1. Ribociclib (600 mg) was dosed orally for the first 21 days out of a 28-day cycle.
2. Letrozole (2.5 mg) or anastrozole (1 mg) were dosed orally daily (28 days out of the 28-day cycle).
3. Goserelin (3.6 mg) was continuously released via a subcutaneous implant injected on Day 1 of each 28-day cycle (regardless of ribociclib treatment cycle) with an administration window of + 3 days.
|
Combination Chemotherapy
n=100 Participants
Combination chemotherapies of docetaxel/capecitabine, paclitaxel/gemcitabine or capecitabine/vinorelbine were administered to patients enrolled in the control group. The chemotherapy regimen was decided by the treating physician.
|
|---|---|---|
|
Number of Patients With Laboratory Abnormalities
Hemoglobin - Hypo: Grades 1/2
|
82 Participants
|
73 Participants
|
|
Number of Patients With Laboratory Abnormalities
Hemoglobin - Hypo: Grade 3
|
5 Participants
|
11 Participants
|
|
Number of Patients With Laboratory Abnormalities
Hemoglobin - Hypo: Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormalities
Leukocytes - Hypo: Grades 1/2
|
71 Participants
|
54 Participants
|
|
Number of Patients With Laboratory Abnormalities
Leukocytes - Hypo: Grade 4
|
0 Participants
|
1 Participants
|
|
Number of Patients With Laboratory Abnormalities
Lymphocytes (absolute) - Hyper: Grades 1/2
|
3 Participants
|
10 Participants
|
|
Number of Patients With Laboratory Abnormalities
Lymphocytes (absolute) - Hyper: Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormalities
Lymphocytes (absolute) - Hyper: Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormalities
Lymphocytes (absolute) - Hypo: Grades 1/2
|
55 Participants
|
37 Participants
|
|
Number of Patients With Laboratory Abnormalities
Lymphocytes (absolute) - Hypo: Grade 3
|
21 Participants
|
3 Participants
|
|
Number of Patients With Laboratory Abnormalities
Neutrophils (absolute) - Hypo: Grades 1/2
|
40 Participants
|
35 Participants
|
|
Number of Patients With Laboratory Abnormalities
Neutrophils (absolute) - Hypo: Grade 3
|
55 Participants
|
23 Participants
|
|
Number of Patients With Laboratory Abnormalities
Neutrophils (absolute) - Hypo: Grade 4
|
10 Participants
|
9 Participants
|
|
Number of Patients With Laboratory Abnormalities
Platelets - Hypo: Grades 1/2
|
37 Participants
|
27 Participants
|
|
Number of Patients With Laboratory Abnormalities
Platelets - Hypo: Grade 3
|
2 Participants
|
2 Participants
|
|
Number of Patients With Laboratory Abnormalities
Prothrombin Intl. Normalized Ratio - Hyper: Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Patients With Laboratory Abnormalities
Leukocytes - Hypo: Grade 3
|
34 Participants
|
8 Participants
|
|
Number of Patients With Laboratory Abnormalities
Lymphocytes (absolute) - Hypo: Grade 4
|
1 Participants
|
4 Participants
|
|
Number of Patients With Laboratory Abnormalities
Platelets - Hypo: Grade 4
|
1 Participants
|
1 Participants
|
|
Number of Patients With Laboratory Abnormalities
Prothrombin Intl. Normalized Ratio - Hyper: Grades 1/2
|
0 Participants
|
8 Participants
|
|
Number of Patients With Laboratory Abnormalities
Prothrombin Intl. Normalized Ratio - Hyper: Grade 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: On-treatment deaths: Up to approximately 46 months. Post-treatment survival follow-up deaths: Up to approximately 2 additional months.Population: All participants to whom study treatment was assigned.
On-treatment deaths due to any cause were collected from first dose of study medication to 30 days after the last dose of study treatment. Post-treatment survival follow-up deaths were collected from day 31 after last dose of study medication to end of study.
Outcome measures
| Measure |
Ribociclib 600 mg
n=112 Participants
Combination of non-steroidal aromatase inhibitor: NSAI (letrozole or anastrozole) + goserelin + ribociclib.
1. Ribociclib (600 mg) was dosed orally for the first 21 days out of a 28-day cycle.
2. Letrozole (2.5 mg) or anastrozole (1 mg) were dosed orally daily (28 days out of the 28-day cycle).
3. Goserelin (3.6 mg) was continuously released via a subcutaneous implant injected on Day 1 of each 28-day cycle (regardless of ribociclib treatment cycle) with an administration window of + 3 days.
|
Combination Chemotherapy
n=100 Participants
Combination chemotherapies of docetaxel/capecitabine, paclitaxel/gemcitabine or capecitabine/vinorelbine were administered to patients enrolled in the control group. The chemotherapy regimen was decided by the treating physician.
|
|---|---|---|
|
Post-Hoc: All Collected Deaths
On-treatment deaths
|
5 Participants
|
0 Participants
|
|
Post-Hoc: All Collected Deaths
Post-treatment survival follow-up deaths
|
29 Participants
|
29 Participants
|
|
Post-Hoc: All Collected Deaths
All deaths
|
34 Participants
|
29 Participants
|
Adverse Events
Ribociclib 600 mg (On-treatment)
Serious events: 17 serious events
Other events: 112 other events
Deaths: 5 deaths
Combination Chemotherapy (On-treatment)
Serious events: 16 serious events
Other events: 100 other events
Deaths: 0 deaths
Ribociclib 600 mg (Post-treatment Survival Follow-up)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 29 deaths
Combination Chemotherapy (Post-treatment Survival Follow-up)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 29 deaths
Serious adverse events
| Measure |
Ribociclib 600 mg (On-treatment)
n=112 participants at risk
AEs during the on-treatment period (up to 30 days post-treatment)
|
Combination Chemotherapy (On-treatment)
n=100 participants at risk
AEs during the on-treatment period (up to 30 days post-treatment)
|
Ribociclib 600 mg (Post-treatment Survival Follow-up)
Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.
|
Combination Chemotherapy (Post-treatment Survival Follow-up)
Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
2/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
2/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.89%
1/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Cardiac disorders
Angina pectoris
|
0.89%
1/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
1.0%
1/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Gastrointestinal disorders
Vomiting
|
0.89%
1/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
General disorders
Disease progression
|
0.89%
1/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
General disorders
Localised oedema
|
0.00%
0/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
1.0%
1/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
General disorders
Non-cardiac chest pain
|
0.89%
1/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
General disorders
Pyrexia
|
0.89%
1/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Abdominal sepsis
|
0.89%
1/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
COVID-19
|
3.6%
4/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
1.0%
1/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
1.0%
1/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
1.0%
1/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.89%
1/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
1.0%
1/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Pneumonia
|
1.8%
2/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
2/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Sepsis
|
1.8%
2/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Urinary tract infection
|
0.89%
1/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
1.0%
1/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
1.0%
1/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.89%
1/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
1.0%
1/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.89%
1/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.89%
1/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
1.0%
1/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
2/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.89%
1/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.00%
0/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
1.0%
1/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
1.0%
1/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.89%
1/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
1.0%
1/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.7%
3/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.8%
2/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
1.0%
1/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.89%
1/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
2/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Social circumstances
Menopause
|
0.89%
1/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
Other adverse events
| Measure |
Ribociclib 600 mg (On-treatment)
n=112 participants at risk
AEs during the on-treatment period (up to 30 days post-treatment)
|
Combination Chemotherapy (On-treatment)
n=100 participants at risk
AEs during the on-treatment period (up to 30 days post-treatment)
|
Ribociclib 600 mg (Post-treatment Survival Follow-up)
Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.
|
Combination Chemotherapy (Post-treatment Survival Follow-up)
Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
35.7%
40/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
42.0%
42/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Leukopenia
|
25.9%
29/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
14.0%
14/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
9.8%
11/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
6.0%
6/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
65.2%
73/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
38.0%
38/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.7%
12/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
7.0%
7/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
16/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
12.0%
12/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
3/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
26.0%
26/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
14/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
27.0%
27/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Gastrointestinal disorders
Stomatitis
|
2.7%
3/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
7.0%
7/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
7/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
30.0%
30/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
General disorders
Fatigue
|
8.0%
9/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
25.0%
25/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
General disorders
Oedema peripheral
|
1.8%
2/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
9.0%
9/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
General disorders
Pyrexia
|
5.4%
6/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
16.0%
16/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
COVID-19
|
15.2%
17/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
10.0%
10/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Cellulitis
|
1.8%
2/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
7.0%
7/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
8/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
4.0%
4/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Alanine aminotransferase increased
|
20.5%
23/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
30.0%
30/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Aspartate aminotransferase increased
|
20.5%
23/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
29.0%
29/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Blood alkaline phosphatase increased
|
10.7%
12/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
8.0%
8/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Blood bilirubin increased
|
5.4%
6/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
1.0%
1/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.2%
7/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
11.0%
11/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Electrocardiogram QT prolonged
|
20.5%
23/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
11.0%
11/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Gamma-glutamyltransferase increased
|
16.1%
18/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
8.0%
8/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Lipase increased
|
6.2%
7/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
2.0%
2/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Lymphocyte count decreased
|
7.1%
8/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
3.0%
3/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
Neutrophil count decreased
|
25.0%
28/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
16.0%
16/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Investigations
White blood cell count decreased
|
24.1%
27/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
12.0%
12/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.7%
3/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
8.0%
8/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.7%
3/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
7.0%
7/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.4%
6/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
7.0%
7/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.4%
6/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
7.0%
7/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.4%
6/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
3.0%
3/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.2%
17/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
7.0%
7/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.7%
12/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
13.0%
13/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.6%
4/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
11.0%
11/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Nervous system disorders
Dizziness
|
6.2%
7/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
6.0%
6/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Nervous system disorders
Headache
|
7.1%
8/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
6.0%
6/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Nervous system disorders
Neuropathy peripheral
|
2.7%
3/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
14.0%
14/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Psychiatric disorders
Insomnia
|
8.0%
9/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
6.0%
6/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.8%
11/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
12.0%
12/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.4%
6/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
6.0%
6/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.7%
12/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
20.0%
20/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.9%
10/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
5.0%
5/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
2.7%
3/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
32.0%
32/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
14/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
7.0%
7/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.9%
10/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
7.0%
7/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Vascular disorders
Hot flush
|
10.7%
12/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
0.00%
0/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
|
Vascular disorders
Hypertension
|
8.0%
9/112 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
1.0%
1/100 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 46 months. Deaths were collected in the post treatment survival follow-up from 31 days after last dose of study medication until the end of the study, up to approximately 2 additional months. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER