Trial Outcomes & Findings for Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer (NCT NCT03176238)
NCT ID: NCT03176238
Last Updated: 2020-04-07
Results Overview
Adverse events (AEs), serious adverse events (SAEs), changes from baseline in vital signs and laboratory results (hematology, blood chemistry, lipid profile) qualifying and reported as AEs. Although a patient might had two or more adverse events the patient is only counted once in a category. The same patient might appear in different categories. AESI: Adverse events of special interest.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
235 participants
Primary outcome timeframe
Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries including a 30 day post treatment follow up period
Results posted on
2020-04-07
Participant Flow
Three hundred eleven participants were screened and 235 enrolled in Asian and non-Asian countries. Primary reason for discontinuation was presented.
Participant milestones
| Measure |
Asian Everolimus + Exemestane
Everolimus (10 Mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Asian countries: Indonesia, India, Vietnam, Turkey, South Korea, Thailand, Malaysia, Taiwan or Jordan.
|
Non-Asian Everolimus + Exemestane
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Non-Asian countries: Australia, Morocco, South Africa or Tunisia.
|
|---|---|---|
|
Overall Study
STARTED
|
199
|
36
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
199
|
36
|
Reasons for withdrawal
| Measure |
Asian Everolimus + Exemestane
Everolimus (10 Mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Asian countries: Indonesia, India, Vietnam, Turkey, South Korea, Thailand, Malaysia, Taiwan or Jordan.
|
Non-Asian Everolimus + Exemestane
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Non-Asian countries: Australia, Morocco, South Africa or Tunisia.
|
|---|---|---|
|
Overall Study
Unacceptable AEs
|
15
|
8
|
|
Overall Study
Abnormal lab value(s)
|
2
|
0
|
|
Overall Study
Inter-current illness
|
0
|
1
|
|
Overall Study
Consent withdrawal
|
14
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Administrative problems
|
1
|
0
|
|
Overall Study
Death
|
3
|
0
|
|
Overall Study
Disease Progression
|
133
|
22
|
|
Overall Study
Tx duration completed per EAP
|
0
|
1
|
|
Overall Study
Patient is switched to commercial drug
|
16
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Changes in the patient's condition
|
2
|
1
|
|
Overall Study
Everolimus dose interrupt > 4 wks
|
9
|
0
|
Baseline Characteristics
Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Asian Everolimus + Exemestane
n=199 Participants
Everolimus (10 Mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Asian countries: Indonesia, India, Vietnam, Turkey, South Korea, Thailand, Malaysia, Taiwan or Jordan.
|
Non-Asian Everolimus + Exemestane
n=36 Participants
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Non-Asian countries: Australia, Morocco, South Africa or Tunisia.
|
Total
n=235 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 10.00 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 10.26 • n=7 Participants
|
58.8 years
STANDARD_DEVIATION 10.05 • n=5 Participants
|
|
Sex/Gender, Customized
Females
|
199 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
235 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
7 participants
n=5 Participants
|
27 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
156 participants
n=5 Participants
|
3 participants
n=7 Participants
|
159 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
36 participants
n=5 Participants
|
6 participants
n=7 Participants
|
42 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries including a 30 day post treatment follow up periodPopulation: Safety analysis set
Adverse events (AEs), serious adverse events (SAEs), changes from baseline in vital signs and laboratory results (hematology, blood chemistry, lipid profile) qualifying and reported as AEs. Although a patient might had two or more adverse events the patient is only counted once in a category. The same patient might appear in different categories. AESI: Adverse events of special interest.
Outcome measures
| Measure |
Asian Everolimus + Exemestane
n=199 Participants
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Asian countries: Indonesia, India, Vietnam, Turkey, South Korea, Thailand, Malaysia, Taiwan or Jordan.
|
Non-Asian Everolimus + Exemestane
n=36 Participants
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Non-Asian countries: Australia, Morocco, South Africa or Tunisia.
|
Total
n=235 Participants
Asian and Non -Asian countries
|
|---|---|---|---|
|
Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades
STEAE leading to death
|
6 Participants
|
4 Participants
|
10 Participants
|
|
Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades
Non-fatal STEAE
|
53 Participants
|
12 Participants
|
65 Participants
|
|
Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades
no TEAE
|
4 Participants
|
0 Participants
|
4 Participants
|
|
Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades
at least 1 TEAE
|
195 Participants
|
36 Participants
|
231 Participants
|
|
Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades
at least 1 drug-related TEAE
|
185 Participants
|
33 Participants
|
218 Participants
|
|
Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades
at least 1 serious TEAE (STEAE)
|
59 Participants
|
16 Participants
|
75 Participants
|
|
Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades
at least 1 drug-related STEAE
|
28 Participants
|
8 Participants
|
36 Participants
|
|
Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades
at least 1 drug-related STEAE - death
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades
at least 1 drug-related non-fatal STEAE
|
26 Participants
|
7 Participants
|
33 Participants
|
|
Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades
TEAE leading to permanent tx discontinuation
|
25 Participants
|
11 Participants
|
36 Participants
|
|
Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades
1 TE AESI
|
172 Participants
|
34 Participants
|
206 Participants
|
SECONDARY outcome
Timeframe: Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countriesPopulation: Full analysis set
The best overall response for each patient is determined from the sequence of investigator overall lesion responses according to RECIST 1.1: Complete Response (CR)=disappearance of target lesions, Partial Response (PR) was \>=30% decrease in sum of diameter of lesions, Progressive Disease (PD) was \>=20% decrease in sum of diameter of lesions, Stable Disease (SD) does not qualify for PR, CR or PD, Unknown=not documented or assessed. To be assigned a best overall response of CR at least two determinations of CR at least 4 weeks apart before progression are required. To be assigned a best overall response of PR at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) are required. The Overall response rate (ORR) is the percentage of patients with a best overall response of confirmed complete (CR) or partial (PR) response. The 95% confidence intervals (CI) were computed using the Clopper-Pearson method
Outcome measures
| Measure |
Asian Everolimus + Exemestane
n=199 Participants
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Asian countries: Indonesia, India, Vietnam, Turkey, South Korea, Thailand, Malaysia, Taiwan or Jordan.
|
Non-Asian Everolimus + Exemestane
n=36 Participants
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Non-Asian countries: Australia, Morocco, South Africa or Tunisia.
|
Total
n=235 Participants
Asian and Non -Asian countries
|
|---|---|---|---|
|
Percentage of Participants Response Rates (Best Overall and Overall)
Progressive disease (PD)
|
18.1 Percentage of participants
Interval 13.0 to 24.2
|
19.4 Percentage of participants
Interval 8.2 to 36.0
|
18.3 Percentage of participants
Interval 13.6 to 23.8
|
|
Percentage of Participants Response Rates (Best Overall and Overall)
Complete response (CR)
|
1.5 Percentage of participants
Interval 0.3 to 4.3
|
0.00 Percentage of participants
Not available for 0 percent response
|
1.3 Percentage of participants
Interval 0.3 to 3.7
|
|
Percentage of Participants Response Rates (Best Overall and Overall)
Partial response (PR)
|
20.1 Percentage of participants
Interval 14.8 to 26.3
|
8.3 Percentage of participants
Interval 1.8 to 22.5
|
18.3 Percentage of participants
Interval 13.6 to 23.8
|
|
Percentage of Participants Response Rates (Best Overall and Overall)
Stable disease (SD)
|
51.3 Percentage of participants
Interval 44.1 to 58.4
|
63.9 Percentage of participants
Interval 46.2 to 79.2
|
53.2 Percentage of participants
Interval 46.6 to 59.7
|
|
Percentage of Participants Response Rates (Best Overall and Overall)
Unknown (UNK)
|
9.0 Percentage of participants
Interval 5.4 to 13.9
|
8.3 Percentage of participants
Interval 1.8 to 22.5
|
8.9 Percentage of participants
Interval 5.6 to 13.3
|
|
Percentage of Participants Response Rates (Best Overall and Overall)
Overall response rate (ORR: CR+PR)
|
21.6 Percentage of participants
Interval 16.1 to 28.0
|
8.3 Percentage of participants
Interval 1.8 to 22.5
|
19.6 Percentage of participants
Interval 14.7 to 25.2
|
SECONDARY outcome
Timeframe: Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countriesPopulation: Full analysis set
Clinical benefit rate: Patients with best overall response rate of CR (any duration), PR (any duration) and SD with duration of 24 weeks or longer according to RECIST 1.1 criteria: Complete Response (CR)=disappearance of target lesions, Partial Response (PR) was \>=30% decrease in sum of diameter of lesions, Progressive Disease (PD) was \>=20% decrease in sum of diameter of lesions, Stable Disease (SD) does not qualify for PR, CR or PD, Unknown=not documented or assessed. Best overall response of CR = at least two determinations of CR at least 4 weeks apart before progression are required. Best overall response of PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) are required. The Overall response rate (ORR) is the percentage of patients with a best overall response of confirmed complete (CR) or partial (PR) response. The 95% confidence intervals (CI) were computed using the Clopper-Pearson method.
Outcome measures
| Measure |
Asian Everolimus + Exemestane
n=199 Participants
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Asian countries: Indonesia, India, Vietnam, Turkey, South Korea, Thailand, Malaysia, Taiwan or Jordan.
|
Non-Asian Everolimus + Exemestane
n=36 Participants
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Non-Asian countries: Australia, Morocco, South Africa or Tunisia.
|
Total
n=235 Participants
Asian and Non -Asian countries
|
|---|---|---|---|
|
Percentage of Participants Clinical Benefit Rate
|
48.2 Percentage of participants
Interval 41.1 to 55.4
|
30.6 Percentage of participants
Interval 16.3 to 48.1
|
45.5 Percentage of participants
Interval 39.0 to 52.1
|
SECONDARY outcome
Timeframe: Baseline up to approximately 43 weeks for Asian countires and 40 weeks for Non-Asian countriesPopulation: Full analysis set
PFS is time from date of start of treatment to date of disease progression or death due to any cause, whichever occurs first. b Percentiles with 95% CIs are calculated from PROC LIFETEST output using method of Brookmeyer and Crowley (1982)
Outcome measures
| Measure |
Asian Everolimus + Exemestane
n=199 Participants
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Asian countries: Indonesia, India, Vietnam, Turkey, South Korea, Thailand, Malaysia, Taiwan or Jordan.
|
Non-Asian Everolimus + Exemestane
n=36 Participants
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Non-Asian countries: Australia, Morocco, South Africa or Tunisia.
|
Total
n=235 Participants
Asian and Non -Asian countries
|
|---|---|---|---|
|
Progression Free Survival (PFS)
|
40.6 weeks
Interval 39.3 to 50.3
|
37.0 weeks
Interval 26.7 to 52.0
|
40.6 weeks
Interval 38.0 to 48.9
|
SECONDARY outcome
Timeframe: Baseline up to approximately 50 weeksPopulation: Number of participants meeting criteria differed at visits
Time to deterioration of ECOG performance status, from baseline will be assessed using the ECOG Performance Status Scale (Oken, 1982). Time to deterioration is the time from date of start of treatment to the date of the event defined as deterioration. Deterioration is defined as an increase in performance status from 0 to 2 or greater, an increase in performance status from 1-2 to 3 or greater, or death due to any cause. Event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. Event-free probability estimates were are obtained from the Kaplan-Meier survival estimates.
Outcome measures
| Measure |
Asian Everolimus + Exemestane
n=199 Participants
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Asian countries: Indonesia, India, Vietnam, Turkey, South Korea, Thailand, Malaysia, Taiwan or Jordan.
|
Non-Asian Everolimus + Exemestane
n=36 Participants
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Non-Asian countries: Australia, Morocco, South Africa or Tunisia.
|
Total
n=235 Participants
Asian and Non -Asian countries
|
|---|---|---|---|
|
Percent of Participants Event-free Probability Estimates of Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status
Week 0 n=199,36,235
|
100.0 percent of participants
|
100.0 percent of participants
|
100.00 percent of participants
|
|
Percent of Participants Event-free Probability Estimates of Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status
Week 20 n=134,18,152
|
95.0 percent of participants
|
79.8 percent of participants
|
92.7 percent of participants
|
|
Percent of Participants Event-free Probability Estimates of Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status
Week 50 n=58,7,65
|
90.6 percent of participants
|
70.4 percent of participants
|
87.6 percent of participants
|
Adverse Events
Asian
Serious events: 59 serious events
Other events: 192 other events
Deaths: 6 deaths
Non-Asian
Serious events: 16 serious events
Other events: 36 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Asian
n=199 participants at risk
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Asian countries: Indonesia, India, Vietnam, Turkey, South Korea, Thailand, Malaysia, Taiwan or Jordan.
|
Non-Asian
n=36 participants at risk
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Non-Asian countries: Australia, Morocco, South Africa or Tunisia.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
Anaemia
|
3.5%
7/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.0%
2/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Atrial fibrillation
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Cardiac arrest
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Cardiac failure
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Left ventricular failure
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Ventricular tachycardia
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.3%
3/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
2/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Dysphagia
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
1.0%
2/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Haematochezia
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.3%
3/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Stomatitis
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Asthenia
|
1.0%
2/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Chills
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Fatigue
|
1.5%
3/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Gait inability
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Oedema peripheral
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Pyrexia
|
2.5%
5/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.3%
3/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Immune system disorders
Contrast media allergy
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Atypical pneumonia
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Cellulitis
|
3.0%
6/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Herpes virus infection
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Influenza
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Pneumonia
|
4.0%
8/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Sepsis
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Soft tissue infection
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Urethritis
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Urinary tract infection
|
1.0%
2/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Urosepsis
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Viral infection
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Overdose
|
1.0%
2/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Eastern cooperative oncology group performance status worsened
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Liver function test increased
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Neutrophil count decreased
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Troponin increased
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Weight decreased
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.0%
2/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.0%
2/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
2/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Central nervous system haemorrhage
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Hydrocephalus
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Intracranial aneurysm
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Lethargy
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.3%
3/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Renal and urinary disorders
Renal failure
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
4/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
4/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.3%
3/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
Other adverse events
| Measure |
Asian
n=199 participants at risk
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Asian countries: Indonesia, India, Vietnam, Turkey, South Korea, Thailand, Malaysia, Taiwan or Jordan.
|
Non-Asian
n=36 participants at risk
Everolimus (10 mg) and exemestane (25 mg) tablets taken orally in combination once daily. Participants in Non-Asian countries: Australia, Morocco, South Africa or Tunisia.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
19.1%
38/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
22.2%
8/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.0%
2/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.3%
3/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.5%
9/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.1%
4/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Palpitations
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Tachycardia
|
1.0%
2/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Eye disorders
Dry eye
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Eye disorders
Eye pain
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Eye disorders
Vision blurred
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.5%
5/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
4.0%
8/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.0%
6/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Aphthous ulcer
|
5.0%
10/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Ascites
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Constipation
|
6.0%
12/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.3%
3/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Dental caries
|
1.0%
2/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
15.1%
30/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
16.7%
6/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
7.5%
15/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.0%
4/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Mouth ulceration
|
3.5%
7/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
25.0%
9/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Nausea
|
11.6%
23/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
25.0%
9/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Oral pain
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Stomatitis
|
62.8%
125/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
38.9%
14/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Toothache
|
4.0%
8/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
6/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.1%
4/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Asthenia
|
5.0%
10/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Face oedema
|
2.5%
5/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Fatigue
|
15.6%
31/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
38.9%
14/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Influenza like illness
|
2.0%
4/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Mucosal inflammation
|
2.0%
4/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Nodule
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Non-cardiac chest pain
|
3.0%
6/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Oedema peripheral
|
8.0%
16/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.9%
5/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Pain
|
1.5%
3/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Peripheral swelling
|
4.0%
8/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Pyrexia
|
6.0%
12/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.3%
3/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Swelling
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Unevaluable event
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Bronchitis
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Candida infection
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Cellulitis
|
2.5%
5/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Ear infection
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Folliculitis
|
1.0%
2/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Furuncle
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Gastroenteritis
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Gingivitis
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Influenza
|
3.0%
6/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Localised infection
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Lower respiratory tract infection
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
6/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Oral herpes
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Pharyngitis
|
2.5%
5/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Pneumonia
|
5.0%
10/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Sinusitis
|
1.0%
2/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Upper respiratory tract infection
|
11.6%
23/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Urinary tract infection
|
4.5%
9/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.3%
3/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Alanine aminotransferase increased
|
22.6%
45/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.1%
4/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Aspartate aminotransferase increased
|
25.1%
50/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.3%
3/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Blood albumin decreased
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Blood alkaline phosphatase increased
|
4.5%
9/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Blood cholesterol increased
|
16.1%
32/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.1%
4/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Blood creatinine increased
|
3.5%
7/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Blood lactate dehydrogenase increased
|
8.5%
17/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Blood triglycerides increased
|
2.0%
4/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Gamma-glutamyltransferase increased
|
15.1%
30/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Haemoglobin decreased
|
2.5%
5/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Liver function test abnormal
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Liver function test increased
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Liver palpable
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Neutrophil count decreased
|
5.0%
10/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Platelet count decreased
|
2.0%
4/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Weight decreased
|
16.1%
32/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.1%
4/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
White blood cell count decreased
|
2.5%
5/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.6%
53/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
25.0%
9/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
3.0%
6/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
5.0%
10/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.0%
10/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
19.4%
7/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
25.6%
51/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
25.0%
9/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.5%
5/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
2.5%
5/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
11.6%
23/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.3%
3/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.0%
8/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.0%
2/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.5%
7/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
2.0%
4/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.0%
16/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.6%
21/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.3%
3/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.0%
2/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.0%
4/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.0%
2/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.5%
3/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.0%
18/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.0%
4/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.0%
14/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.3%
3/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroma
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Dizziness
|
2.0%
4/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Dysgeusia
|
6.5%
13/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.1%
4/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Headache
|
11.6%
23/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.1%
4/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Hypoaesthesia
|
2.0%
4/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Paraesthesia
|
2.5%
5/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Psychiatric disorders
Agitation
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Psychiatric disorders
Depression
|
2.5%
5/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Psychiatric disorders
Insomnia
|
9.0%
18/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.9%
5/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Reproductive system and breast disorders
Breast pain
|
1.0%
2/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.1%
44/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
11.1%
4/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.0%
16/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.9%
5/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.0%
2/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.5%
9/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
25.0%
9/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.0%
6/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
3/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
12.6%
25/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
16.7%
6/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.0%
16/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.0%
8/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.0%
8/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.5%
5/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
2.5%
5/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
10/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
8.3%
3/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.5%
3/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
3.0%
6/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
1.0%
2/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
2.0%
4/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
22/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
24.1%
48/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
33.3%
12/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.0%
4/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.5%
7/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
Hot flush
|
0.50%
1/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
13.9%
5/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
Hypertension
|
6.0%
12/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
Hypotension
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
Lymphoedema
|
5.0%
10/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.6%
2/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
Phlebitis
|
0.00%
0/199 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
1/36 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration off approximately 43 weeks for Asian countries and 32 weeks for Non-Asian countries
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER