Trial Outcomes & Findings for Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer (NCT NCT02500043)
NCT ID: NCT02500043
Last Updated: 2024-09-03
Results Overview
OS was defined as the time from the date of randomization to the date of death due to any cause. Participants without documented death were censored at last follow-up or cut-off date, whichever comes first. OS was estimated by Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
507 participants
Primary outcome timeframe
From the date of randomization to the data cut-off date (maximum duration: up to approximately 46 months)
Results posted on
2024-09-03
Participant Flow
The study was conducted at study centers in 17 countries. Participants were involved in the study from 24 February 2016 to 19 December 2019.
Overall, 625 participants were screened, of which 118 were screen failures due to inclusion/exclusion criteria not met and 507 were randomized and treated with TAS-102 or placebo along with Best supportive care (BSC) (BSC was given to prevent, control, or relieve complications and side effects with the intention to maximize quality of life (QoL) without a specific antineoplastic regimen).
Participant milestones
| Measure |
TAS-102+BSC
Participants received 35 milligrams per meter square (mg/m\^2) of TAS-102 tablets orally twice daily (BID) for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
|
Placebo+BSC
Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
|
|---|---|---|
|
Overall Study
STARTED
|
337
|
170
|
|
Overall Study
As-Treated (AT) Population
|
335
|
168
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
337
|
170
|
Reasons for withdrawal
| Measure |
TAS-102+BSC
Participants received 35 milligrams per meter square (mg/m\^2) of TAS-102 tablets orally twice daily (BID) for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
|
Placebo+BSC
Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
|
|---|---|---|
|
Overall Study
Randomized, but not Treated
|
2
|
2
|
|
Overall Study
Ongoing at Date of Cut-Off
|
19
|
3
|
|
Overall Study
Adverse Event
|
33
|
11
|
|
Overall Study
Clinical Progression
|
54
|
35
|
|
Overall Study
Radiological Progression
|
192
|
110
|
|
Overall Study
Physician's Decision
|
11
|
3
|
|
Overall Study
Withdrawal by Subject
|
14
|
4
|
|
Overall Study
Death
|
11
|
2
|
|
Overall Study
Protocol Deviation
|
1
|
0
|
Baseline Characteristics
Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer
Baseline characteristics by cohort
| Measure |
TAS-102+BSC
n=337 Participants
Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
|
Placebo+BSC
n=170 Participants
Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
|
Total
n=507 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.8 Years
STANDARD_DEVIATION 10.78 • n=99 Participants
|
62.0 Years
STANDARD_DEVIATION 10.04 • n=107 Participants
|
62.5 Years
STANDARD_DEVIATION 10.53 • n=206 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
138 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
252 Participants
n=99 Participants
|
117 Participants
n=107 Participants
|
369 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
244 Participants
n=99 Participants
|
113 Participants
n=107 Participants
|
357 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
51 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not collectable
|
38 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
European Cooperative Oncology Group (ECOG) Performance Status
ECOG Grade 0
|
123 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
191 Participants
n=206 Participants
|
|
European Cooperative Oncology Group (ECOG) Performance Status
ECOG Grade 1
|
214 Participants
n=99 Participants
|
102 Participants
n=107 Participants
|
316 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization to the data cut-off date (maximum duration: up to approximately 46 months)Population: Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered.
OS was defined as the time from the date of randomization to the date of death due to any cause. Participants without documented death were censored at last follow-up or cut-off date, whichever comes first. OS was estimated by Kaplan-Meier method.
Outcome measures
| Measure |
TAS-102+BSC
n=337 Participants
Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
|
Placebo+BSC
n=170 Participants
Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
|
|---|---|---|
|
Overall Survival (OS)
|
5.7 months
Interval 4.8 to 6.2
|
3.6 months
Interval 3.1 to 4.1
|
SECONDARY outcome
Timeframe: From the date of randomization to the cut-off date (maximum duration: up to approximately 46 months)Population: Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered.
PFS was defined as the time from randomization until the date of first occurrence of investigator-assessed radiological disease progression or death due to any cause, whichever came first. Disease progression as per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) for target lesions were defined as target lesions with at least 20 % relative increase in the sum of diameters with reference to the smallest sum on study, including the baseline sum and this sum demonstrated an absolute increase of at least 5 millimeter (mm) or the appearance of one or more new lesions or Unequivocal progression of existing non-target lesions. All alive participants with no disease progression as of the analysis cut-off date were censored at the last tumor assessment. PFS was estimated by Kaplan-Meier method.
Outcome measures
| Measure |
TAS-102+BSC
n=337 Participants
Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
|
Placebo+BSC
n=170 Participants
Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
2.0 months
Interval 1.9 to 2.3
|
1.8 months
Interval 1.7 to 1.9
|
SECONDARY outcome
Timeframe: From the first dose of study treatment until 30 days after the last dose of study treatment (maximum duration: up to approximately 46 months)Population: Analysis was performed on the As-treated (AT) population that included all participants who received at least 1 dose of study treatment.
Any untoward medical condition that occurs in a participants while participating in a clinical study and does not necessarily have a causal relationship with the use of the study medication was considered an adverse event (AE). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs/TESAEs were defined as events that started on or after treatment or started before treatment and worsened after the start of treatment through 30 days after the last dose of study treatment.
Outcome measures
| Measure |
TAS-102+BSC
n=335 Participants
Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
|
Placebo+BSC
n=168 Participants
Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE)
TEAE
|
319 Participants
|
151 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE)
TESAE
|
143 Participants
|
70 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the date of randomization to the cut-off date (maximum duration: up to approximately 46 months), assessed every 8 weeksPopulation: Analysis was performed on tumor response (TR) population that included participants in the ITT population that met 2 criteria: had measurable disease (at least 1 target lesion) at baseline; had at least 1 post-baseline evaluation or early disease progression/cancer-related death occurred before first evaluation on treatment (post-baseline).
Overall response rate was defined as the percentage of participants with objective evidence of complete response (CR) or partial response (PR). CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes for target lesions or all lymph nodes for non-target lesions were non-pathological morphologically that was reduced in size in short axis to \< 10 mm. PR was defined as target lesions with at least 30% decrease in the sum of diameters, taking baseline sum diameters as reference.
Outcome measures
| Measure |
TAS-102+BSC
n=290 Participants
Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
|
Placebo+BSC
n=145 Participants
Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
|
|---|---|---|
|
Overall Response Rate (ORR)
|
4.5 percentage of participants
Interval 2.4 to 7.5
|
2.1 percentage of participants
Interval 0.4 to 5.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the date of randomization to the cut-off date (maximum duration: up to approximately 46 months), assessed every 8 weeksPopulation: Analysis was performed on TR population that included participants in the ITT population that met 2 criteria: had measurable disease (at least 1 target lesion) at baseline; had at least 1 post-baseline evaluation or early disease progression/cancer-related death occurred before first evaluation on treatment (post-baseline).
DCR was defined as the proportion of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD). The assessment of DCR was based on Investigator review of radiologic images and following RECIST criteria (version 1.1, 2009).
Outcome measures
| Measure |
TAS-102+BSC
n=290 Participants
Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
|
Placebo+BSC
n=145 Participants
Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
|
|---|---|---|
|
Disease Control Rate (DCR)
|
44.1 percentage of participants
Interval 38.3 to 50.1
|
14.5 percentage of participants
Interval 9.2 to 21.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the time of randomization (Day 1 Cycle 1) and within 24 hours prior to start of study treatment in every cycle (maximum duration: up to approximately 46 months)Population: Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered.
The ECOG performance status was used to evaluate participant's disease progression and the effect of the disease on the participant's activities of daily living. It ranges on the scale from 0-5 (0 = normal activity; 1= symptoms but ambulatory; 2= in bed for \< 50% of the time; 3= in bed for \> 50% of the time; 4= 100% bedridden; 5= dead). Time to definitive deterioration in ECOG performance status score from baseline was defined as a change from 0, 1 to \>=2, or from 2 to \>=3.
Outcome measures
| Measure |
TAS-102+BSC
n=337 Participants
Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
|
Placebo+BSC
n=170 Participants
Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
|
|---|---|---|
|
Time to Deterioration of European Cooperative Oncology Group (ECOG) Performance Status Score From Baseline
|
4.3 months
Interval 3.7 to 4.7
|
2.3 months
Interval 2.0 to 2.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 1 Cycle 2 up to end of treatment (EOT) (within 30 days of last study treatment) and 30-Day safety follow-up visit (maximum duration: up to approximately 46 months)Population: Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered. Here, 'number analyzed' = participants with available data for each specified category.
EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) and other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health and QoL, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 and 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best QoL for participant.
Outcome measures
| Measure |
TAS-102+BSC
n=337 Participants
Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
|
Placebo+BSC
n=170 Participants
Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
|
|---|---|---|
|
Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health Status
Cycle 1
|
-2.7 units on a scale
Standard Deviation 17.56
|
-5.9 units on a scale
Standard Deviation 22.20
|
|
Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health Status
Cycle 2
|
-5.9 units on a scale
Standard Deviation 20.51
|
-7.3 units on a scale
Standard Deviation 25.80
|
|
Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health Status
Cycle 3
|
-4.1 units on a scale
Standard Deviation 18.26
|
-1.4 units on a scale
Standard Deviation 22.00
|
|
Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health Status
Cycle 4
|
-3.6 units on a scale
Standard Deviation 17.54
|
-1.7 units on a scale
Standard Deviation 22.32
|
|
Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health Status
Cycle 5
|
-5.9 units on a scale
Standard Deviation 18.05
|
11.1 units on a scale
Standard Deviation 18.16
|
|
Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health Status
Cycle 6
|
-8.8 units on a scale
Standard Deviation 23.05
|
15.6 units on a scale
Standard Deviation 21.10
|
|
Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health Status
Cycle 7
|
-9.5 units on a scale
Standard Deviation 21.96
|
20.0 units on a scale
Standard Deviation 4.56
|
|
Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health Status
Cycle 8
|
-4.3 units on a scale
Standard Deviation 23.82
|
16.7 units on a scale
Standard Deviation 11.79
|
|
Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health Status
Cycle 9
|
2.4 units on a scale
Standard Deviation 17.12
|
16.7 units on a scale
Standard Deviation 16.67
|
|
Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health Status
Cycle 10
|
-14.4 units on a scale
Standard Deviation 25.57
|
25.0 units on a scale
Standard Deviation 11.79
|
|
Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health Status
Cycle 11
|
-16.7 units on a scale
Standard Deviation 37.27
|
25.0 units on a scale
Standard Deviation 11.79
|
|
Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health Status
Cycle 12
|
-8.3 units on a scale
Standard Deviation 11.79
|
33.3 units on a scale
|
|
Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health Status
Cycle 13
|
0.0 units on a scale
|
33.3 units on a scale
|
|
Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health Status
Cycle 14
|
—
|
33.3 units on a scale
|
|
Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health Status
Cycle 15
|
—
|
33.3 units on a scale
|
|
Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health Status
Last Collection Cycle
|
-8.8 units on a scale
Standard Deviation 20.91
|
-9.8 units on a scale
Standard Deviation 25.34
|
|
Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health Status
Safety Follow-Up
|
-16.5 units on a scale
Standard Deviation 23.45
|
-8.9 units on a scale
Standard Deviation 18.33
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Cycle 1 Day 1 up to end of treatment (EOT) (within 30 days of last study treatment) (maximum duration: up to approximately 46 months)Population: Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered.
The Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) assessed symptoms and treatment-related side effects commonly reported in participants. There are 22 questions which comprise 5 scales (dysphagia, dietary restrictions, pain QS22, reflux, and anxiety) and 4 single items (dry mouth, hair loss, taste problems, body image). Most questions use 4-point scale (1='Not at all', 2=a little, 3=quite a bit and 4='Very much'). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100, where higher score=better level of functioning or greater degree of symptoms.
Outcome measures
| Measure |
TAS-102+BSC
n=337 Participants
Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
|
Placebo+BSC
n=170 Participants
Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
|
|---|---|---|
|
EORTC Quality of Life Questionnaire - Gastric-specific Module (EORTC QLQ-STO22): Percentage of Participants With Overall Compliance
Dysphagia
|
86.6 percentage of participants
|
78.2 percentage of participants
|
|
EORTC Quality of Life Questionnaire - Gastric-specific Module (EORTC QLQ-STO22): Percentage of Participants With Overall Compliance
Dietary Restrictions
|
86.6 percentage of participants
|
78.2 percentage of participants
|
|
EORTC Quality of Life Questionnaire - Gastric-specific Module (EORTC QLQ-STO22): Percentage of Participants With Overall Compliance
Pain QS22
|
86.6 percentage of participants
|
78.2 percentage of participants
|
|
EORTC Quality of Life Questionnaire - Gastric-specific Module (EORTC QLQ-STO22): Percentage of Participants With Overall Compliance
Reflux
|
86.6 percentage of participants
|
78.2 percentage of participants
|
|
EORTC Quality of Life Questionnaire - Gastric-specific Module (EORTC QLQ-STO22): Percentage of Participants With Overall Compliance
Anxiety
|
86.6 percentage of participants
|
78.2 percentage of participants
|
|
EORTC Quality of Life Questionnaire - Gastric-specific Module (EORTC QLQ-STO22): Percentage of Participants With Overall Compliance
Dry Mouth
|
86.4 percentage of participants
|
78.2 percentage of participants
|
|
EORTC Quality of Life Questionnaire - Gastric-specific Module (EORTC QLQ-STO22): Percentage of Participants With Overall Compliance
Body Image
|
85.8 percentage of participants
|
78.2 percentage of participants
|
|
EORTC Quality of Life Questionnaire - Gastric-specific Module (EORTC QLQ-STO22): Percentage of Participants With Overall Compliance
Hair Loss
|
86.6 percentage of participants
|
78.2 percentage of participants
|
|
EORTC Quality of Life Questionnaire - Gastric-specific Module (EORTC QLQ-STO22): Percentage of Participants With Overall Compliance
Taste Problems
|
86.6 percentage of participants
|
78.2 percentage of participants
|
Adverse Events
TAS-102+BSC
Serious events: 143 serious events
Other events: 319 other events
Deaths: 252 deaths
Placebo+BSC
Serious events: 70 serious events
Other events: 151 other events
Deaths: 141 deaths
Serious adverse events
| Measure |
TAS-102+BSC
n=335 participants at risk
Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
|
Placebo+BSC
n=168 participants at risk
Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
|
|---|---|---|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Blood bilirubin increased
|
0.30%
1/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Neutrophil count decreased
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
White blood cell count decreased
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Alkalosis hypochloraemic
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.3%
11/335 • Number of events 11 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
2.4%
4/168 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer metastatic
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Altered state of consciousness
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Cerebral infarction
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.8%
3/168 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.30%
1/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.9%
13/335 • Number of events 13 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
2.4%
4/168 • Number of events 5 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.30%
1/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.2%
4/335 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.2%
4/335 • Number of events 5 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.1%
7/335 • Number of events 7 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Cardiac disorders
Atrial fibrillation
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Cardiac disorders
Cardio-Respiratory arrest
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Cardiac disorders
Myocardial infarction
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Ear and labyrinth disorders
Vertigo
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
8/335 • Number of events 8 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
3.6%
6/168 • Number of events 6 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Ascites
|
0.90%
3/335 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
4.2%
7/168 • Number of events 7 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Constipation
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
6/335 • Number of events 6 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Dysphagia
|
1.8%
6/335 • Number of events 6 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.90%
3/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.8%
3/168 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Gastric stenosis
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.2%
4/335 • Number of events 6 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Haematemesis
|
0.90%
3/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Ileus
|
0.60%
2/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.2%
4/335 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.8%
3/168 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Nausea
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.90%
3/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Ulcerative gastritis
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
9/335 • Number of events 9 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Asthenia
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.8%
3/168 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Disease progression
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Fatigue
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
General physical health deterioration
|
6.3%
21/335 • Number of events 25 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
8.9%
15/168 • Number of events 20 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Malaise
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Pain
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Performance status decreased
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Pyrexia
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Hepatobiliary disorders
Cholangitis
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Hepatobiliary disorders
Cholestasis
|
0.30%
1/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Hepatobiliary disorders
Jaundice
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Clostridium difficile infection
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Escherichia sepsis
|
0.30%
1/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Infection
|
0.60%
2/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Influenza
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Neutropenic sepsis
|
1.2%
4/335 • Number of events 6 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Pneumonia
|
1.2%
4/335 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Salmonellosis
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Sepsis
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Septic shock
|
0.90%
3/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Typhoid fever
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Urosepsis
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Headache
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Hemiparesis
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Presyncope
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Renal and urinary disorders
Renal failure
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Reproductive system and breast disorders
Breast pain
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
4/335 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
5/335 • Number of events 6 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.5%
5/335 • Number of events 5 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.30%
1/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Vascular disorders
Hypotension
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Vascular disorders
Lymphoedema
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Vascular disorders
Shock haemorrhagic
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Vascular disorders
Venous thrombosis
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
Other adverse events
| Measure |
TAS-102+BSC
n=335 participants at risk
Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
|
Placebo+BSC
n=168 participants at risk
Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
42.4%
142/335 • Number of events 249 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
17.9%
30/168 • Number of events 52 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
38.2%
128/335 • Number of events 312 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
3.6%
6/168 • Number of events 9 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Blood bilirubin unconjugated increased
|
0.30%
1/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Blood creatinine decreased
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Blood creatinine increased
|
3.0%
10/335 • Number of events 11 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
3.6%
6/168 • Number of events 11 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Blood iron decreased
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Blood potassium increased
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Blood and lymphatic system disorders
Leukopenia
|
17.0%
57/335 • Number of events 116 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.8%
3/168 • Number of events 14 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.0%
20/335 • Number of events 42 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
4.8%
8/168 • Number of events 21 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.30%
1/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.6%
32/335 • Number of events 45 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Cardiac disorders
Angina pectoris
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Cardiac disorders
Atrial flutter
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Cardiac disorders
Bradycardia
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Cardiac disorders
Palpitations
|
1.8%
6/335 • Number of events 6 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Cardiac disorders
Pericardial effusion
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Cardiac disorders
Tachycardia
|
0.60%
2/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Ear and labyrinth disorders
Ear pain
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Ear and labyrinth disorders
Vertigo
|
0.90%
3/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Eye disorders
Dry eye
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Eye disorders
Eye irritation
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Eye disorders
Eye pain
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Eye disorders
Eye pruritus
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Eye disorders
Lacrimation increased
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Eye disorders
Visual impairment
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.90%
3/335 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.9%
13/335 • Number of events 15 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
5.4%
9/168 • Number of events 9 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.9%
50/335 • Number of events 75 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
16.1%
27/168 • Number of events 34 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.90%
3/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.6%
22/335 • Number of events 27 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
8.3%
14/168 • Number of events 15 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Anal inflammation
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Anal pruritus
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.30%
1/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Ascites
|
4.8%
16/335 • Number of events 24 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
6.0%
10/168 • Number of events 18 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Cheilitis
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Constipation
|
13.1%
44/335 • Number of events 53 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
14.9%
25/168 • Number of events 31 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Diarrhoea
|
21.8%
73/335 • Number of events 118 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
14.3%
24/168 • Number of events 28 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Dry mouth
|
0.90%
3/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
2.4%
4/168 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Dyschezia
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.5%
5/335 • Number of events 7 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.8%
3/168 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Dysphagia
|
4.2%
14/335 • Number of events 16 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
3.6%
6/168 • Number of events 6 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Eructation
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Flatulence
|
0.60%
2/335 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Gastric stenosis
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.2%
4/335 • Number of events 5 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Haematemesis
|
0.90%
3/335 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Haematochezia
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Ileus
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Intra-Abdominal fluid collection
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Melaena
|
0.90%
3/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Nausea
|
36.7%
123/335 • Number of events 201 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
31.5%
53/168 • Number of events 64 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Odynophagia
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Proctalgia
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Stomatitis
|
4.5%
15/335 • Number of events 17 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.8%
3/168 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Toothache
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Gastrointestinal disorders
Vomiting
|
23.9%
80/335 • Number of events 104 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
20.2%
34/168 • Number of events 48 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Asthenia
|
19.4%
65/335 • Number of events 97 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
22.0%
37/168 • Number of events 45 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Catheter site pain
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Chest discomfort
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Chest pain
|
0.90%
3/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Chills
|
1.2%
4/335 • Number of events 6 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Drug intolerance
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Early satiety
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Face oedema
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Facial pain
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Fatigue
|
26.0%
87/335 • Number of events 136 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
20.8%
35/168 • Number of events 41 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Feeling abnormal
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Feeling cold
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Feeling hot
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Gait disturbance
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
General physical health deterioration
|
0.90%
3/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.8%
3/168 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Hyperthermia
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Hypothermia
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Localised oedema
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Malaise
|
2.7%
9/335 • Number of events 16 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
4.8%
8/168 • Number of events 8 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Mucosal inflammation
|
2.4%
8/335 • Number of events 11 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.8%
3/168 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Non-Cardiac chest pain
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Oedema
|
2.4%
8/335 • Number of events 8 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Oedema peripheral
|
5.1%
17/335 • Number of events 17 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
7.1%
12/168 • Number of events 12 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Pain
|
1.5%
5/335 • Number of events 6 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
4.8%
8/168 • Number of events 8 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Performance status decreased
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Peripheral swelling
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
General disorders
Pyrexia
|
6.9%
23/335 • Number of events 37 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
4.8%
8/168 • Number of events 9 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Hepatobiliary disorders
Biliary colic
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
3.0%
10/335 • Number of events 10 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.8%
3/168 • Number of events 5 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.30%
1/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Hepatobiliary disorders
Jaundice
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Hepatobiliary disorders
Liver disorder
|
1.2%
4/335 • Number of events 6 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Immune system disorders
Perfume sensitivity
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Angular cheilitis
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Bronchitis
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Candida infection
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Cellulitis
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Clostridium difficile infection
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Conjunctivitis
|
0.90%
3/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Cystitis
|
0.90%
3/335 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Erysipelas
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Gastrointestinal infection
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Gingival abscess
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Herpes virus infection
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Herpes zoster
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Influenza
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Laryngitis
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Localised infection
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.90%
3/335 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Lung infection
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
5/335 • Number of events 5 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Oral candidiasis
|
1.8%
6/335 • Number of events 6 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Pneumonia
|
1.2%
4/335 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Pyuria
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Respiratory tract infection
|
0.90%
3/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Rhinitis
|
0.90%
3/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Sinusitis
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Skin infection
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Staphylococcal infection
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Tonsillitis
|
0.60%
2/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.4%
8/335 • Number of events 9 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Urinary tract infection
|
2.7%
9/335 • Number of events 15 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
2.4%
4/168 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Injury, poisoning and procedural complications
Fall
|
0.90%
3/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.8%
3/168 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Injury, poisoning and procedural complications
Foreign body in gastrointestinal tract
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Injury, poisoning and procedural complications
Radiation injury
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Alanine aminotransferase
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Alanine aminotransferase increased
|
4.8%
16/335 • Number of events 17 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
4.8%
8/168 • Number of events 8 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Aspartate aminotransferase
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Aspartate aminotransferase increased
|
6.3%
21/335 • Number of events 26 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
7.7%
13/168 • Number of events 15 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Bilirubin conjugated increased
|
0.30%
1/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Blood alkaline phosphatase
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Blood alkaline phosphatase increased
|
9.0%
30/335 • Number of events 35 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
8.3%
14/168 • Number of events 15 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Blood bilirubin
|
0.30%
1/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Blood bilirubin increased
|
5.1%
17/335 • Number of events 27 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
4.2%
7/168 • Number of events 9 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Blood urea increased
|
2.1%
7/335 • Number of events 9 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
4.2%
7/168 • Number of events 8 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Creatinine renal clearance decreased
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Enzyme level increased
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Gamma-Glutamyltransferase increased
|
1.2%
4/335 • Number of events 6 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
3.0%
5/168 • Number of events 6 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Haematocrit decreased
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Haemoglobin decreased
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Hepatic enzyme increased
|
0.90%
3/335 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
International normalised ratio increased
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Liver function test increased
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Lymphocyte count decreased
|
0.60%
2/335 • Number of events 7 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Neutrophil count
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Neutrophil count decreased
|
14.9%
50/335 • Number of events 139 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Platelet count decreased
|
8.4%
28/335 • Number of events 43 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
3.6%
6/168 • Number of events 11 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Platelet count increased
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Protein total decreased
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Red blood cell count decreased
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Red cell distribution width increased
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Vital capacity abnormal
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Weight decreased
|
6.0%
20/335 • Number of events 21 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
7.1%
12/168 • Number of events 13 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
Weight increased
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Investigations
White blood cell count decreased
|
6.9%
23/335 • Number of events 59 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.90%
3/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
32.5%
109/335 • Number of events 164 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
29.2%
49/168 • Number of events 54 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
4/335 • Number of events 6 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Feeding intolerance
|
0.30%
1/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.7%
9/335 • Number of events 10 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
3.0%
5/168 • Number of events 5 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.30%
1/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.8%
3/168 • Number of events 5 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.3%
21/335 • Number of events 28 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
6.0%
10/168 • Number of events 11 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.7%
9/335 • Number of events 11 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.7%
9/335 • Number of events 11 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.8%
3/168 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.1%
7/335 • Number of events 7 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.8%
3/168 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.5%
5/335 • Number of events 6 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
4.2%
7/168 • Number of events 8 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
6/335 • Number of events 7 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.5%
25/335 • Number of events 31 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
5.4%
9/168 • Number of events 10 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.90%
3/335 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Musculoskeletal and connective tissue disorders
Bone swelling
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.90%
3/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.5%
5/335 • Number of events 6 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.2%
4/335 • Number of events 5 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.90%
3/335 • Number of events 5 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue disorder
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.90%
3/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Agnosia
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Amnesia
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Burning sensation
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Dizziness
|
2.4%
8/335 • Number of events 10 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
2.4%
4/168 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Dysgeusia
|
3.3%
11/335 • Number of events 17 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Headache
|
1.8%
6/335 • Number of events 8 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
2.4%
4/168 • Number of events 5 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Lethargy
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.8%
3/168 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Monoplegia
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Myoclonus
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Neuralgia
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.2%
4/335 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Paraesthesia
|
2.4%
8/335 • Number of events 8 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Sciatica
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Somnolence
|
1.5%
5/335 • Number of events 5 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Product Issues
Device dislocation
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Psychiatric disorders
Agitation
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Psychiatric disorders
Anxiety
|
2.7%
9/335 • Number of events 9 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
2.4%
4/168 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Psychiatric disorders
Confusional state
|
0.60%
2/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.8%
3/168 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Psychiatric disorders
Delirium
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Psychiatric disorders
Depression
|
0.90%
3/335 • Number of events 5 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Psychiatric disorders
Disturbance in social behaviour
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Psychiatric disorders
Drug abuse
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Psychiatric disorders
Hallucination
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Psychiatric disorders
Insomnia
|
3.3%
11/335 • Number of events 12 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
6.0%
10/168 • Number of events 10 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Psychiatric disorders
Nervousness
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.60%
2/335 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Renal and urinary disorders
Albuminuria
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Renal and urinary disorders
Choluria
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Renal and urinary disorders
Dysuria
|
1.5%
5/335 • Number of events 5 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.8%
3/168 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Renal and urinary disorders
Leukocyturia
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Renal and urinary disorders
Microalbuminuria
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Renal and urinary disorders
Micturition disorder
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Renal and urinary disorders
Nocturia
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Renal and urinary disorders
Pollakiuria
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Renal and urinary disorders
Proteinuria
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Renal and urinary disorders
Urinary retention
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Reproductive system and breast disorders
Breast pain
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Reproductive system and breast disorders
Pelvic discomfort
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.8%
3/168 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
11/335 • Number of events 12 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
3.6%
6/168 • Number of events 7 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.90%
3/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.3%
21/335 • Number of events 24 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
9.5%
16/168 • Number of events 16 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.2%
4/335 • Number of events 5 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.2%
4/335 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
3.0%
5/168 • Number of events 5 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.0%
10/335 • Number of events 11 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
2.4%
4/168 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.2%
4/335 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.5%
5/335 • Number of events 5 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.6%
12/335 • Number of events 14 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.5%
5/335 • Number of events 5 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.90%
3/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar erythrodysaesthesia syndrome
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.4%
8/335 • Number of events 9 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
4/335 • Number of events 5 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Vascular disorders
Deep vein thrombosis
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Vascular disorders
Embolism
|
0.60%
2/335 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Vascular disorders
Hot flush
|
0.00%
0/335 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
1.2%
2/168 • Number of events 2 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Vascular disorders
Hypertension
|
0.90%
3/335 • Number of events 3 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Vascular disorders
Hypotension
|
2.1%
7/335 • Number of events 7 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.60%
1/168 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Vascular disorders
Pallor
|
0.60%
2/335 • Number of events 4 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Vascular disorders
Phlebitis
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
|
Vascular disorders
Thrombophlebitis
|
0.30%
1/335 • Number of events 1 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
0.00%
0/168 • From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Analysis was performed on the AT population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place