Trial Outcomes & Findings for A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment (NCT NCT01702571)
NCT ID: NCT01702571
Last Updated: 2022-04-04
Results Overview
The AEPIs in this study were defined as the following: adverse events (AEs) Grade \>/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade \>/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2185 participants
Primary outcome timeframe
Baseline up to approximately 7 years
Results posted on
2022-04-04
Participant Flow
Cohort 1 has 2003 participants and Cohort 2 has 182 participants representing the total enrollment study number. Cohort 1 was conducted in 281 centers in 40 countries worldwide whereas Cohort 2 was conducted in an Asian population in 14 centers in China, Thailand and Indonesia.
Two participants (one in Corhort 1 and Corhot 2) were not included in the safety population as one didn't receive study treatment and one did not qualify under the inclusion criteria.
Participant milestones
| Measure |
Trastuzumab Emtansine (All Participants)
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
Trastuzumab Emtansine (Asian Participants)
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
|---|---|---|
|
Overall Study
STARTED
|
2003
|
182
|
|
Overall Study
COMPLETED
|
494
|
65
|
|
Overall Study
NOT COMPLETED
|
1509
|
117
|
Reasons for withdrawal
| Measure |
Trastuzumab Emtansine (All Participants)
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
Trastuzumab Emtansine (Asian Participants)
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
|---|---|---|
|
Overall Study
Death
|
1067
|
76
|
|
Overall Study
Lost to Follow-up
|
144
|
10
|
|
Overall Study
Adverse Event/Unacceptable Toxicity
|
4
|
0
|
|
Overall Study
Investigator Decision
|
5
|
0
|
|
Overall Study
Not Classifiable
|
1
|
0
|
|
Overall Study
On Study Treatment At Lplv/Cohort 1
|
93
|
0
|
|
Overall Study
On Study Treatment At Lplv/Cohort 2
|
0
|
1
|
|
Overall Study
Progressive Disease
|
3
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Safety FU Done < 3 Months Prior To CCOD
|
9
|
1
|
|
Overall Study
Termination By Sponsor
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
177
|
29
|
Baseline Characteristics
A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment
Baseline characteristics by cohort
| Measure |
Trastuzumab Emtansine (All Participants)
n=2003 Participants
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
Trastuzumab Emtansine (Asian Participants)
n=182 Participants
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
Total
n=2185 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.5 Years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
49.1 Years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
54.1 Years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1989 Participants
n=5 Participants
|
182 Participants
n=7 Participants
|
2171 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
1397 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1397 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
21 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
72 Participants
n=5 Participants
|
182 Participants
n=7 Participants
|
254 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
41 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
N/A as per local regulation
|
997 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
1013 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
247 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
247 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
417 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
436 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
300 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
300 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
29 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Indian (Indian subcontinent)
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to approximately 7 yearsPopulation: The safety population included all participants who had received at least 1 dose of study medication.
The AEPIs in this study were defined as the following: adverse events (AEs) Grade \>/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade \>/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades.
Outcome measures
| Measure |
Trastuzumab Emtansine (All Participants)
n=2002 Participants
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
Trastuzumab Emtansine (Asian Participants)
n=181 Participants
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
|---|---|---|
|
Percentage of Participants With Adverse Events of Primary Interest (AEPIs)
|
23.1 Percentage of Participants
Interval 21.2 to 25.0
|
51.4 Percentage of Participants
Interval 43.9 to 58.9
|
SECONDARY outcome
Timeframe: Baseline up to approximately 7 yearsPopulation: The safety population included all participants who had received at least 1 dose of study medication.
The AEPIs in this study were defined as the following: adverse events (AEs) Grade \>/= 3, specifically, hepatic events, allergic reactions, thrombocytopenia and hemorrhage events, all Grade \>/= 3 AEs related to trastuzumab emtansine and pneumonitis events of all grades.
Outcome measures
| Measure |
Trastuzumab Emtansine (All Participants)
n=2002 Participants
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
Trastuzumab Emtansine (Asian Participants)
n=181 Participants
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
|---|---|---|
|
Percentage of Participants With Specific AEPIs
AEs Grade >/= 3 for hepatic events
|
6.9 Percentage of Participants
|
12.2 Percentage of Participants
|
|
Percentage of Participants With Specific AEPIs
AEs Grade >/= 3 for allergic reactions
|
2.3 Percentage of Participants
|
1.1 Percentage of Participants
|
|
Percentage of Participants With Specific AEPIs
AEs Grade >/= 3 for thrombocytopenia
|
3.7 Percentage of Participants
|
36.5 Percentage of Participants
|
|
Percentage of Participants With Specific AEPIs
AEs Grade >/= 3 for hemorrhage events
|
2.3 Percentage of Participants
|
1.7 Percentage of Participants
|
|
Percentage of Participants With Specific AEPIs
AEs Grade >/= 3 related to trastuzumab emtansine
|
18.4 Percentage of Participants
|
48.6 Percentage of Participants
|
|
Percentage of Participants With Specific AEPIs
Pneumonitis of all grades
|
1.0 Percentage of Participants
|
2.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline up to approximately 7 yearsPopulation: The safety population included all participants who had received at least 1 dose of study medication.
AESIs included: 1) Potential drug-induced liver injury, which included any potential case of drug-induced liver injury as, assessed by laboratory criteria for Hy's law (AST and/or ALT elevations that were \>3 × ULN, Concurrent elevation of total bilirubin \>2 × ULN (or clinical jaundice if total bilirubin measures were not available), except in participants with documented Gilbert's syndrome. Those with Gilbert's syndrome, elevation of direct bilirubin \>2 × ULN was used instead. 2) Suspected transmission of an infectious agent by study drug was defined as any organism, virus, or infectious particle (e.g., prion protein transmitting transmissible spongiform encephalopathy), pathogenic or non-pathogenic. A transmission of an infectious agent suspected from clinical symptoms or laboratory findings indicating an infection in a participant exposed to a medicinal product.
Outcome measures
| Measure |
Trastuzumab Emtansine (All Participants)
n=2002 Participants
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
Trastuzumab Emtansine (Asian Participants)
n=181 Participants
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
|---|---|---|
|
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Potential drug-induced liver injury
|
1.2 Percentage of Participants
|
1.1 Percentage of Participants
|
|
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Suspected transmission of an infectious agent
|
0.2 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)Population: Intent to Treat (ITT) Population included all participants enrolled in the study.
Progression free survival is defined as the time (in months) between the date of first dose and the date of disease progression or death from any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Outcome measures
| Measure |
Trastuzumab Emtansine (All Participants)
n=2003 Participants
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
Trastuzumab Emtansine (Asian Participants)
n=182 Participants
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
|---|---|---|
|
Progression-Free Survival According to Response Evaluation for Solid Tumors (RECIST) Version (v) 1.1 As Per Investigator Assessment
|
6.8 months
Interval 5.8 to 7.6
|
5.7 months
Interval 5.5 to 7.0
|
SECONDARY outcome
Timeframe: Baseline until death (up to approximately 7 years)Population: ITT Population included all participants enrolled in the study.
Overall survival is defined as time to death, which is the time from the date of dosing until the date of death, regardless of the cause of death.
Outcome measures
| Measure |
Trastuzumab Emtansine (All Participants)
n=2003 Participants
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
Trastuzumab Emtansine (Asian Participants)
n=182 Participants
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
|---|---|---|
|
Overall Survival
|
27.2 months
Interval 25.5 to 28.7
|
29.5 months
Interval 21.1 to
The confidence interval has no upper limit
|
SECONDARY outcome
Timeframe: Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)Population: ITT Population included all participants enrolled in the study. Only participants with measurable disease were included in the analysis.
Best Overall Response reported here is the Best confirmed Overall Response. To be assigned a status of PR or CR, i.e., to be a responder, changes in tumor measurements had to be confirmed by repeat assessments that had to be performed no less than 4 weeks after the criteria for response were first met, i.e., participants needed to have two consecutive assessments of PR or CR. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
Outcome measures
| Measure |
Trastuzumab Emtansine (All Participants)
n=1613 Participants
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
Trastuzumab Emtansine (Asian Participants)
n=169 Participants
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
|---|---|---|
|
Percentage of Participants With Best Overall Response (Complete Response [CR] or Partial Response [PR]) According to RECIST v 1.1 As Per Investigator Assessment
|
29.3 Percentage of Participants
Interval 27.1 to 31.6
|
29.6 Percentage of Participants
Interval 22.8 to 37.1
|
SECONDARY outcome
Timeframe: Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)Population: ITT Population included all participants enrolled in the study. Only participants with measurable disease were included in the analysis.
Clinical Benefit was defined as CR plus PR plus SD. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD: neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.
Outcome measures
| Measure |
Trastuzumab Emtansine (All Participants)
n=1613 Participants
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
Trastuzumab Emtansine (Asian Participants)
n=169 Participants
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
|---|---|---|
|
Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD]) According to RECIST v 1.1
|
47.1 Percentage of Participants
Interval 44.7 to 49.6
|
39.6 Percentage of Participants
Interval 32.2 to 47.4
|
SECONDARY outcome
Timeframe: Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)Population: ITT Population included all participants enrolled in the study. Only participants with measurable disease were included in the analysis.
DOR is defined as the period from the date of initial confirmed PR or CR (whichever occurs first) until the date of PD or death from any cause. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
Outcome measures
| Measure |
Trastuzumab Emtansine (All Participants)
n=1613 Participants
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
Trastuzumab Emtansine (Asian Participants)
n=169 Participants
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
|---|---|---|
|
Duration of Response (DOR) According to RECIST v 1.1
|
13.8 months
Interval 12.2 to 15.0
|
14.2 months
Interval 11.1 to 24.4
|
SECONDARY outcome
Timeframe: Baseline up to disease progression or death due to any cause, whichever occurs first (assessed every 12 weeks during treatment period thereafter 28-42 days after the last dose or every 3-6 months up to approximately 7 years)Population: ITT Population included all participants enrolled in the study. Only responders were included in the analysis.
Time to Response is defined as the time from first dose to first documentation of confirmed PR or CR (whichever occurs first). CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
Outcome measures
| Measure |
Trastuzumab Emtansine (All Participants)
n=473 Participants
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
Trastuzumab Emtansine (Asian Participants)
n=50 Participants
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
|---|---|---|
|
Time to Response According to RECIST v 1.1
|
22.3 months
Interval 11.8 to 38.2
|
8.3 months
Interval 5.7 to
The confidence interval has no upper limit
|
SECONDARY outcome
Timeframe: Baseline up to approximately 7 yearsPopulation: The safety population included all participants who had received at least 1 dose of study medication.
The number of hospital visits were recorded to evaluate the resoruce expenditures while participants were on study treatment.
Outcome measures
| Measure |
Trastuzumab Emtansine (All Participants)
n=2002 Participants
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
Trastuzumab Emtansine (Asian Participants)
n=181 Participants
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
|---|---|---|
|
Number of Hospital Visits
|
2.7 Number of Hospital Visits
Standard Deviation 2.78
|
2.1 Number of Hospital Visits
Standard Deviation 1.70
|
SECONDARY outcome
Timeframe: Baseline up to approximately 7 yearsPopulation: The safety population included all participants who had received at least 1 dose of study medication.
The type of hospital visits (intensive care unit (ICU) versus other) were recorded to evaluate the resoruce expenditures while participants were on study treatment. The number of participants with at least one ICU visit are based on the number of participants with at least one hospital visit, in each group.
Outcome measures
| Measure |
Trastuzumab Emtansine (All Participants)
n=2002 Participants
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
Trastuzumab Emtansine (Asian Participants)
n=181 Participants
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
|---|---|---|
|
Type of Hospital Visits
Other Hospital Visit
|
558 Participants
|
33 Participants
|
|
Type of Hospital Visits
ICU Visit
|
39 Participants
|
0 Participants
|
Adverse Events
Trastuzumab Emtansine (All Participants)
Serious events: 427 serious events
Other events: 1734 other events
Deaths: 1072 deaths
Trastuzumab Emtansine (Asian Participants)
Serious events: 36 serious events
Other events: 170 other events
Deaths: 77 deaths
Serious adverse events
| Measure |
Trastuzumab Emtansine (All Participants)
n=2002 participants at risk
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
Trastuzumab Emtansine (Asian Participants)
n=181 participants at risk
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.65%
13/2002 • Number of events 14 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Blood and lymphatic system disorders
BONE MARROW FAILURE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Blood and lymphatic system disorders
DISSEMINATED INTRAVASCULAR COAGULATION
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.55%
11/2002 • Number of events 11 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
5.5%
10/181 • Number of events 11 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.15%
3/2002 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.55%
1/181 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Cardiac disorders
CARDIAC TAMPONADE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Cardiac disorders
PALPITATIONS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.55%
1/181 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.15%
3/2002 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Eye disorders
BLINDNESS
|
0.05%
1/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Eye disorders
CATARACT
|
0.00%
0/2002 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.55%
1/181 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Eye disorders
RETINAL VEIN THROMBOSIS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.20%
4/2002 • Number of events 12 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.55%
1/181 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
ANAL FISSURE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
ANAL HAEMORRHAGE
|
0.10%
2/2002 • Number of events 4 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
ASCITES
|
0.10%
2/2002 • Number of events 6 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
COLITIS
|
0.15%
3/2002 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.15%
3/2002 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.20%
4/2002 • Number of events 4 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
DUODENAL ULCER
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
DUODENAL ULCER HAEMORRHAGE
|
0.05%
1/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.10%
2/2002 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
GASTRIC ANTRAL VASCULAR ECTASIA
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
GASTRIC HAEMORRHAGE
|
0.05%
1/2002 • Number of events 10 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.15%
3/2002 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
GASTRITIS EROSIVE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
GASTRODUODENAL ULCER
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.15%
3/2002 • Number of events 10 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
GLOSSITIS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.10%
2/2002 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
0.05%
1/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.55%
1/181 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
MELAENA
|
0.10%
2/2002 • Number of events 8 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
NAUSEA
|
0.25%
5/2002 • Number of events 6 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.55%
1/181 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
OESOPHAGEAL FISTULA
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
OESOPHAGEAL VARICES HAEMORRHAGE
|
0.05%
1/2002 • Number of events 4 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.05%
1/2002 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
PERIODONTAL DISEASE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
PROCTALGIA
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.05%
1/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
SMALL INTESTINAL HAEMORRHAGE
|
0.05%
1/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
SUBILEUS
|
0.10%
2/2002 • Number of events 4 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
TOOTH LOSS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.15%
3/2002 • Number of events 6 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
1.1%
2/181 • Number of events 6 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
VOMITING
|
0.85%
17/2002 • Number of events 19 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.55%
1/181 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
General disorders
ASTHENIA
|
0.15%
3/2002 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
General disorders
CATHETER SITE ERYTHEMA
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
General disorders
CHILLS
|
0.10%
2/2002 • Number of events 6 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
General disorders
DEATH
|
0.25%
5/2002 • Number of events 5 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
General disorders
FATIGUE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.20%
4/2002 • Number of events 4 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
General disorders
HYPERTHERMIA
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
General disorders
IMPLANT SITE DEHISCENCE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
General disorders
INFLAMMATION
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
General disorders
MALAISE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
General disorders
MULTIPLE ORGAN DYSFUNCTION SYNDROME
|
0.15%
3/2002 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.55%
1/181 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
General disorders
PYREXIA
|
0.65%
13/2002 • Number of events 42 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
General disorders
SUDDEN DEATH
|
0.00%
0/2002 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.55%
1/181 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.15%
3/2002 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Hepatobiliary disorders
CHOLESTASIS
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Hepatobiliary disorders
DRUG-INDUCED LIVER INJURY
|
0.05%
1/2002 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.55%
1/181 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.25%
5/2002 • Number of events 10 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Hepatobiliary disorders
HEPATIC PAIN
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Hepatobiliary disorders
HEPATOTOXICITY
|
0.35%
7/2002 • Number of events 14 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Hepatobiliary disorders
JAUNDICE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Hepatobiliary disorders
NODULAR REGENERATIVE HYPERPLASIA
|
0.15%
3/2002 • Number of events 6 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Hepatobiliary disorders
NON-CIRRHOTIC PORTAL HYPERTENSION
|
0.05%
1/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Hepatobiliary disorders
PORTAL HYPERTENSION
|
0.10%
2/2002 • Number of events 4 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Immune system disorders
ALLERGIC OEDEMA
|
0.05%
1/2002 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.10%
2/2002 • Number of events 6 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
ABSCESS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
ACINETOBACTER INFECTION
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
ARTHRITIS INFECTIVE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
BACTERAEMIA
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
BACTERIAL INFECTION
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
BRAIN ABSCESS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
BREAST CELLULITIS
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
BRONCHITIS
|
0.15%
3/2002 • Number of events 4 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
CATHETER SITE INFECTION
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
CELLULITIS
|
0.40%
8/2002 • Number of events 10 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
CYSTITIS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
DENGUE HAEMORRHAGIC FEVER
|
0.00%
0/2002 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.55%
1/181 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.30%
6/2002 • Number of events 6 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
ENCEPHALITIS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
ENDOCARDITIS
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
ERYSIPELAS
|
0.20%
4/2002 • Number of events 5 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
GASTROENTERITIS
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
GASTROENTERITIS NOROVIRUS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
GASTROINTESTINAL VIRAL INFECTION
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
HERPES ZOSTER
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
INFECTION
|
0.15%
3/2002 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
INFECTIOUS PLEURAL EFFUSION
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
INFECTIVE EXACERBATION OF BRONCHIECTASIS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
INTERVERTEBRAL DISCITIS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
KLEBSIELLA BACTERAEMIA
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
LISTERIOSIS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
LIVER ABSCESS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.45%
9/2002 • Number of events 10 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
MASTITIS
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
MENINGITIS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
OTITIS MEDIA
|
0.15%
3/2002 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
PERITONITIS
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
PHARYNGITIS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.55%
1/181 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
PNEUMOCOCCAL INFECTION
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
PNEUMONIA
|
1.1%
22/2002 • Number of events 23 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
4.4%
8/181 • Number of events 8 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
PNEUMONIA STREPTOCOCCAL
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
PNEUMONIA VIRAL
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
PYELONEPHRITIS CHRONIC
|
0.05%
1/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
SEPSIS
|
0.45%
9/2002 • Number of events 9 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
SKIN INFECTION
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
SOFT TISSUE INFECTION
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
STAPHYLOCOCCAL BACTERAEMIA
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
STAPHYLOCOCCAL SEPSIS
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
STREPTOCOCCAL INFECTION
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
TRACHEOBRONCHITIS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.15%
3/2002 • Number of events 4 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.55%
11/2002 • Number of events 12 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
VASCULAR DEVICE INFECTION
|
0.15%
3/2002 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
VIRAL INFECTION
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.05%
1/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
VULVAL ABSCESS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Injury, poisoning and procedural complications
ANASTOMOTIC ULCER
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Injury, poisoning and procedural complications
FALL
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.20%
4/2002 • Number of events 4 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.40%
8/2002 • Number of events 8 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Injury, poisoning and procedural complications
FOREARM FRACTURE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.15%
3/2002 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
0.10%
2/2002 • Number of events 6 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Injury, poisoning and procedural complications
INTENTIONAL OVERDOSE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Injury, poisoning and procedural complications
PELVIC FRACTURE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Injury, poisoning and procedural complications
RADIATION NECROSIS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Injury, poisoning and procedural complications
SKELETAL INJURY
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Injury, poisoning and procedural complications
SPLENIC INJURY
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.05%
1/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Investigations
AMYLASE INCREASED
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.15%
3/2002 • Number of events 4 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.55%
1/181 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Investigations
ECG SIGNS OF MYOCARDIAL ISCHAEMIA
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.15%
3/2002 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.15%
3/2002 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Investigations
LIVER FUNCTION TEST INCREASED
|
0.00%
0/2002 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.55%
1/181 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Investigations
PLATELET COUNT DECREASED
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
4.4%
8/181 • Number of events 12 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Investigations
TRANSAMINASES INCREASED
|
0.00%
0/2002 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.55%
1/181 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.15%
3/2002 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.15%
3/2002 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.55%
1/181 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
BONE LESION
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
HAEMATOMA MUSCLE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
KYPHOSIS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
MOBILITY DECREASED
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.15%
3/2002 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS OF JAW
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
SPINAL PAIN
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
SYSTEMIC LUPUS ERYTHEMATOSUS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN NEOPLASM
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER METASTATIC
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER PAIN
|
0.15%
3/2002 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MENINGIOMA
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO BONE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC UTERINE CANCER
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NAEVUS HAEMORRHAGE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SARCOMA
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN NEOPLASM BLEEDING
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
APHASIA
|
0.10%
2/2002 • Number of events 4 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
ATAXIA
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
BRAIN OEDEMA
|
0.30%
6/2002 • Number of events 7 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
CENTRAL NERVOUS SYSTEM NECROSIS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.20%
4/2002 • Number of events 8 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.55%
1/181 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.05%
1/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
DIZZINESS
|
0.15%
3/2002 • Number of events 4 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
EPILEPSY
|
0.40%
8/2002 • Number of events 15 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
|
0.15%
3/2002 • Number of events 6 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
HAEMORRHAGIC STROKE
|
0.05%
1/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
HEADACHE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
HEMIPARESIS
|
0.25%
5/2002 • Number of events 5 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
IIIRD NERVE PARESIS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
LEUKOENCEPHALOPATHY
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
MIGRAINE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
MOTOR DYSFUNCTION
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
NERVOUS SYSTEM DISORDER
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
PARTIAL SEIZURES
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
PRESYNCOPE
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
SCIATICA
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
SEIZURE
|
0.35%
7/2002 • Number of events 11 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
VOCAL CORD PARALYSIS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Product Issues
DEVICE BREAKAGE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Product Issues
DEVICE EXTRUSION
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Product Issues
DEVICE LOOSENING
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Psychiatric disorders
AGITATION
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Psychiatric disorders
ANXIETY
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Psychiatric disorders
COMPLETED SUICIDE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.20%
4/2002 • Number of events 4 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Psychiatric disorders
DEPRESSION
|
0.15%
3/2002 • Number of events 4 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Psychiatric disorders
HALLUCINATION
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.10%
2/2002 • Number of events 4 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Renal and urinary disorders
RENAL COLIC
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.20%
4/2002 • Number of events 4 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Renal and urinary disorders
RENAL INJURY
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Reproductive system and breast disorders
CYSTOCELE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Reproductive system and breast disorders
METRORRHAGIA
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Reproductive system and breast disorders
UTERINE HAEMORRHAGE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Reproductive system and breast disorders
UTERINE POLYP
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.55%
1/181 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
ASPIRATION
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMATIC CRISIS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
CHOKING
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.35%
7/2002 • Number of events 24 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.35%
7/2002 • Number of events 8 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.20%
4/2002 • Number of events 4 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.15%
3/2002 • Number of events 4 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.30%
6/2002 • Number of events 6 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.25%
5/2002 • Number of events 5 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY ALVEOLAR HAEMORRHAGE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.15%
3/2002 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY FIBROSIS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.55%
1/181 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY TRACT HAEMORRHAGE
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Skin and subcutaneous tissue disorders
SPIDER NAEVUS
|
0.05%
1/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Surgical and medical procedures
BREAST CONSERVING SURGERY
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Surgical and medical procedures
SCAR EXCISION
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Vascular disorders
CIRCULATORY COLLAPSE
|
0.05%
1/2002 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Vascular disorders
EMBOLISM
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Vascular disorders
HAEMATOMA
|
0.10%
2/2002 • Number of events 2 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Vascular disorders
HYPOTENSION
|
0.05%
1/2002 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Vascular disorders
VENA CAVA THROMBOSIS
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Vascular disorders
VENOUS THROMBOSIS LIMB
|
0.05%
1/2002 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
Other adverse events
| Measure |
Trastuzumab Emtansine (All Participants)
n=2002 participants at risk
This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
Trastuzumab Emtansine (Asian Participants)
n=181 participants at risk
This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
8.6%
173/2002 • Number of events 231 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
14.9%
27/181 • Number of events 49 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.95%
19/2002 • Number of events 23 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
8.3%
15/181 • Number of events 69 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
3.9%
79/2002 • Number of events 151 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
9.4%
17/181 • Number of events 72 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
8.2%
165/2002 • Number of events 257 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
26.0%
47/181 • Number of events 157 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
6.9%
139/2002 • Number of events 182 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
3.3%
6/181 • Number of events 8 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
6.7%
135/2002 • Number of events 163 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
2.8%
5/181 • Number of events 5 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
CONSTIPATION
|
19.7%
394/2002 • Number of events 568 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
5.5%
10/181 • Number of events 38 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
DIARRHOEA
|
12.6%
252/2002 • Number of events 376 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
5.0%
9/181 • Number of events 9 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
DRY MOUTH
|
14.1%
283/2002 • Number of events 303 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
3.9%
7/181 • Number of events 13 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
4.1%
83/2002 • Number of events 96 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
7.7%
14/181 • Number of events 19 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
NAUSEA
|
32.5%
651/2002 • Number of events 1204 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
15.5%
28/181 • Number of events 45 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
STOMATITIS
|
8.0%
160/2002 • Number of events 213 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
2.2%
4/181 • Number of events 6 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Gastrointestinal disorders
VOMITING
|
14.7%
294/2002 • Number of events 408 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
9.4%
17/181 • Number of events 24 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
General disorders
ASTHENIA
|
24.5%
491/2002 • Number of events 828 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
9.9%
18/181 • Number of events 44 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
General disorders
FATIGUE
|
27.8%
556/2002 • Number of events 846 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
6.6%
12/181 • Number of events 17 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
5.3%
107/2002 • Number of events 161 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
1.7%
3/181 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
General disorders
OEDEMA PERIPHERAL
|
5.1%
102/2002 • Number of events 115 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
3.3%
6/181 • Number of events 10 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
General disorders
PAIN
|
4.2%
85/2002 • Number of events 92 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
5.5%
10/181 • Number of events 11 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
General disorders
PYREXIA
|
16.9%
339/2002 • Number of events 1599 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
26.0%
47/181 • Number of events 243 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.8%
136/2002 • Number of events 195 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
4.4%
8/181 • Number of events 13 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
4.0%
80/2002 • Number of events 107 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
7.7%
14/181 • Number of events 18 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
7.8%
157/2002 • Number of events 230 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
2.2%
4/181 • Number of events 4 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
4.3%
86/2002 • Number of events 100 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
32.0%
58/181 • Number of events 133 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
6.8%
136/2002 • Number of events 156 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
42.5%
77/181 • Number of events 143 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
2.6%
52/2002 • Number of events 52 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
7.7%
14/181 • Number of events 16 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
4.4%
89/2002 • Number of events 171 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
16.6%
30/181 • Number of events 85 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
4.2%
84/2002 • Number of events 94 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
11.6%
21/181 • Number of events 31 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
1.8%
36/2002 • Number of events 58 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
11.0%
20/181 • Number of events 84 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Investigations
PLATELET COUNT DECREASED
|
4.5%
91/2002 • Number of events 124 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
30.4%
55/181 • Number of events 191 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Investigations
TRANSAMINASES INCREASED
|
1.3%
27/2002 • Number of events 28 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
9.9%
18/181 • Number of events 39 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Investigations
WEIGHT DECREASED
|
5.3%
106/2002 • Number of events 109 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
4.4%
8/181 • Number of events 8 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.55%
11/2002 • Number of events 13 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
11.0%
20/181 • Number of events 85 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
16.0%
320/2002 • Number of events 398 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
8.8%
16/181 • Number of events 23 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.65%
13/2002 • Number of events 13 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
6.1%
11/181 • Number of events 14 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
3.6%
73/2002 • Number of events 91 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
10.5%
19/181 • Number of events 37 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
13.2%
265/2002 • Number of events 349 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
3.3%
6/181 • Number of events 7 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
9.9%
199/2002 • Number of events 226 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
2.8%
5/181 • Number of events 5 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
6.2%
124/2002 • Number of events 154 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.55%
1/181 • Number of events 1 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
6.7%
135/2002 • Number of events 150 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
1.7%
3/181 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
10.2%
205/2002 • Number of events 279 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
4.4%
8/181 • Number of events 11 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
7.4%
148/2002 • Number of events 169 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
1.7%
3/181 • Number of events 3 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
DIZZINESS
|
5.8%
117/2002 • Number of events 137 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
6.1%
11/181 • Number of events 17 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
HEADACHE
|
22.7%
454/2002 • Number of events 650 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
10.5%
19/181 • Number of events 32 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
PARAESTHESIA
|
6.4%
128/2002 • Number of events 139 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
2.2%
4/181 • Number of events 5 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
5.6%
113/2002 • Number of events 132 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
0.00%
0/181 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Psychiatric disorders
INSOMNIA
|
5.9%
118/2002 • Number of events 134 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
6.1%
11/181 • Number of events 13 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
11.0%
220/2002 • Number of events 256 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
12.7%
23/181 • Number of events 28 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
10.5%
211/2002 • Number of events 705 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
1.1%
2/181 • Number of events 6 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
20.1%
402/2002 • Number of events 669 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
16.6%
30/181 • Number of events 43 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
|
Vascular disorders
HYPERTENSION
|
4.8%
96/2002 • Number of events 113 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
6.6%
12/181 • Number of events 17 • Baseline up to approximately 7 years
The analysis of AEs focused on treatment-emergent AEs (TEAEs) which were AEs that occurred on the day of or after first administration of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER