Trial Outcomes & Findings for A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer (NCT NCT03975647)
NCT ID: NCT03975647
Last Updated: 2026-03-30
Results Overview
PFS as per investigator was defined as the time from the date of randomization to the investigator assessment of disease progression (PD) as per RECIST v1.1 or death from any cause, whichever occurred first. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimiter (mm). Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
466 participants
Primary outcome timeframe
From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months)
Results posted on
2026-03-30
Participant Flow
Participants diagnosed with locally advanced (LA) or metastatic human epidermal growth factor receptor 2 positive (HER2+) breast cancer who received prior treatment with a taxane and trastuzumab in any setting, were evaluated for efficacy and safety of tucatinib in combination with ado-trastuzumab emtansine (T-DM1) in this study.
A total of 618 participants were screened of which 152 failed screening and 466 participants were enrolled in the study.
Participant milestones
| Measure |
Tucatinib+ Ado-trastuzumab Emtansine
Participants with HER2+ LA/mBC were treated with tucatinib 300 mg orally twice a day (BID) and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
|
Placebo+ Ado-trastuzumab Emtansine
Participants with HER2+ LA/mBC were treated with placebo orally BID, and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
|
|---|---|---|
|
Overall Study
STARTED
|
231
|
235
|
|
Overall Study
Intent-to-Treat (ITT) Analysis Set
|
228
|
235
|
|
Overall Study
COMPLETED
|
151
|
159
|
|
Overall Study
NOT COMPLETED
|
80
|
76
|
Reasons for withdrawal
| Measure |
Tucatinib+ Ado-trastuzumab Emtansine
Participants with HER2+ LA/mBC were treated with tucatinib 300 mg orally twice a day (BID) and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
|
Placebo+ Ado-trastuzumab Emtansine
Participants with HER2+ LA/mBC were treated with placebo orally BID, and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
|
|---|---|---|
|
Overall Study
Death
|
71
|
63
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Subject withdrawal of consent
|
7
|
11
|
Baseline Characteristics
A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer
Baseline characteristics by cohort
| Measure |
Tucatinib+ Ado-trastuzumab Emtansine
n=228 Participants
Participants with HER2+ LA/mBC were treated with tucatinib 300 mg orally BID and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
|
Placebo+ Ado-trastuzumab Emtansine
n=235 Participants
Participants with HER2+ LA/mBC were treated with placebo orally BID, and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
|
Total
n=463 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.8 Years
STANDARD_DEVIATION 11.4 • n=4 Participants
|
52.9 Years
STANDARD_DEVIATION 10.9 • n=28 Participants
|
53.4 Years
STANDARD_DEVIATION 11.1 • n=10 Participants
|
|
Sex: Female, Male
Female
|
226 Participants
n=4 Participants
|
235 Participants
n=28 Participants
|
461 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
2 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=4 Participants
|
13 Participants
n=28 Participants
|
21 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
171 Participants
n=4 Participants
|
163 Participants
n=28 Participants
|
334 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
49 Participants
n=4 Participants
|
59 Participants
n=28 Participants
|
108 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
1 Participants
n=28 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
66 Participants
n=4 Participants
|
65 Participants
n=28 Participants
|
131 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=4 Participants
|
8 Participants
n=28 Participants
|
19 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
101 Participants
n=4 Participants
|
102 Participants
n=28 Participants
|
203 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=4 Participants
|
1 Participants
n=28 Participants
|
6 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
42 Participants
n=4 Participants
|
58 Participants
n=28 Participants
|
100 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months)Population: The ITT analysis set included all participants who were randomized on or before the date of LPI, in the global study.
PFS as per investigator was defined as the time from the date of randomization to the investigator assessment of disease progression (PD) as per RECIST v1.1 or death from any cause, whichever occurred first. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimiter (mm). Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment.
Outcome measures
| Measure |
Placebo+ Ado-trastuzumab Emtansine
n=235 Participants
Participants with HER2+ LA/mBC were treated with placebo orally BID, and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
|
Tucatinib+ Ado-trastuzumab Emtansine
n=228 Participants
Participants with HER2+ LA/mBC were treated with tucatinib 300 mg orally BID and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
|
|---|---|---|
|
Progression-Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 Based on Investigator Assessment
|
7.4 Months
Interval 5.6 to 8.1
|
9.5 Months
Interval 7.4 to 10.9
|
SECONDARY outcome
Timeframe: Up to approximately 5 yearsOS was defined as the time from randomization to death due to any cause. For a participant who was not known to have died by the end of study follow-up, observation of OS was censored on the date the participant was last known to be alive (i.e., the date of last contact).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 45 months)Population: The ITT analysis set included all participants who were randomized on or before the date of LPI, in the global study. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.
PFS as per investigator was defined as the time from the date of randomization to the investigator assessment of PD as per RECIST v1.1 or death from any cause, whichever occurred first. PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. PFS was analyzed in participants with presence or history of brain metastases.
Outcome measures
| Measure |
Placebo+ Ado-trastuzumab Emtansine
n=105 Participants
Participants with HER2+ LA/mBC were treated with placebo orally BID, and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
|
Tucatinib+ Ado-trastuzumab Emtansine
n=99 Participants
Participants with HER2+ LA/mBC were treated with tucatinib 300 mg orally BID and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
|
|---|---|---|
|
Progression-Free Survival as Per RECIST v1.1 in Participants With Brain Metastases at Baseline Based on Investigator Assessment
|
5.7 Months
Interval 4.6 to 7.5
|
7.8 Months
Interval 6.7 to 10.0
|
SECONDARY outcome
Timeframe: From the date of first CR or PR until the date of the first documentation of PD or death, whichever occurred first (maximum up to 43 months)Population: The ITT analysis set included all participants who were randomized on or before the date of LPI, in the global study. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.
ORR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than (\<)10 mm. PR: a greater than equal (\>=) 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. ORR by investigator assessment is based on investigator response assessments. Two-sided 95% exact confidence interval, computed using the Clopper-Pearson method.
Outcome measures
| Measure |
Placebo+ Ado-trastuzumab Emtansine
n=191 Participants
Participants with HER2+ LA/mBC were treated with placebo orally BID, and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
|
Tucatinib+ Ado-trastuzumab Emtansine
n=188 Participants
Participants with HER2+ LA/mBC were treated with tucatinib 300 mg orally BID and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
|
|---|---|---|
|
Objective Response Rate (ORR) as Per RECIST v1.1 Based on Investigator Assessment
|
36.1 Percentage of participants
Interval 29.3 to 43.4
|
42.0 Percentage of participants
Interval 34.9 to 49.4
|
SECONDARY outcome
Timeframe: Up to approximately 5 yearsOS was defined as the time from randomization to death due to any cause. For a participant who was not known to have died by the end of study follow-up, observation of OS was censored on the date the participant was last known to be alive (i.e., the date of last contact). OS was analyzed in participants with presence or history of brain metastases.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months)Population: The ITT analysis set included all participants who were randomized on or before the date of LPI, in the global study.
PFS as per BICR was defined as the time from the date of randomization to the centrally-reviewed documented PD as per RECIST v1.1 or death from any cause, whichever occurred first. PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without documented progression of PD or death at the time of analysis were censored at the date of the last tumor assessment.
Outcome measures
| Measure |
Placebo+ Ado-trastuzumab Emtansine
n=235 Participants
Participants with HER2+ LA/mBC were treated with placebo orally BID, and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
|
Tucatinib+ Ado-trastuzumab Emtansine
n=228 Participants
Participants with HER2+ LA/mBC were treated with tucatinib 300 mg orally BID and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
|
|---|---|---|
|
Progression-Free Survival as Per RECIST v1.1 Determined by Blinded Independent Committee Review (BICR)
|
7.4 Months
Interval 5.5 to 8.4
|
9.6 Months
Interval 7.5 to 10.9
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months)Population: The ITT analysis set included all participants who were randomized on or before the date of LPI, in the global study. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.
PFS as per BICR was defined as the time from the date of randomization to the centrally-reviewed documented PD as per RECIST v1.1 or death from any cause, whichever occurred first. PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PFS was analyzed in participants with presence or history of brain metastases.
Outcome measures
| Measure |
Placebo+ Ado-trastuzumab Emtansine
n=105 Participants
Participants with HER2+ LA/mBC were treated with placebo orally BID, and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
|
Tucatinib+ Ado-trastuzumab Emtansine
n=99 Participants
Participants with HER2+ LA/mBC were treated with tucatinib 300 mg orally BID and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
|
|---|---|---|
|
Progression-Free Survival in Participants With Brain Metastases at Baseline as Per RECIST v1.1 Determined by BICR
|
5.5 Months
Interval 4.2 to 7.4
|
7.8 Months
Interval 6.9 to 10.0
|
SECONDARY outcome
Timeframe: From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months)Population: The ITT analysis set included all participants who were randomized on or before the date of LPI, in the global study. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.
ORR was defined as the percentage of participants with confirmed CR or PR according to RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: A \>= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR per BICR is based on BICR response assessments.
Outcome measures
| Measure |
Placebo+ Ado-trastuzumab Emtansine
n=185 Participants
Participants with HER2+ LA/mBC were treated with placebo orally BID, and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
|
Tucatinib+ Ado-trastuzumab Emtansine
n=182 Participants
Participants with HER2+ LA/mBC were treated with tucatinib 300 mg orally BID and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
|
|---|---|---|
|
Objective Response Rate as Per RECIST v1.1 Determined by BICR
|
41.1 Percentage of participants
Interval 33.9 to 48.5
|
47.3 Percentage of participants
Interval 39.8 to 54.8
|
SECONDARY outcome
Timeframe: Up to approximately 5 yearsDOR was defined as the time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD as per RECIST v1.1 PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: A\>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. DOR per investigator was based on investigator response assessments.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 5 yearsDOR was defined as the time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD as per RECIST v1.1 PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: A\>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. DOR per BICR was based on BICR response assessments.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 5 yearsCBR was defined as the percentage of participants with stable disease (SD) or non-CR or non-PD \>= 6 months or best response of CR or PR according to RECIST v1.1. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: A \>= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CBR was based on investigator assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 5 yearsCBR was defined as the percentage of participants with SD or non-CR or non-PD \>= 6 months or best response of CR or PR according to RECIST v1.1. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: A \>= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CBR per BICR is based on BICR response assessments.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment up to 30 days after the last study treatment (approximately 43 months)Population: The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE was defined as AE that is newly occurred or worsened after the start of study treatment.
Outcome measures
| Measure |
Placebo+ Ado-trastuzumab Emtansine
n=233 Participants
Participants with HER2+ LA/mBC were treated with placebo orally BID, and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
|
Tucatinib+ Ado-trastuzumab Emtansine
n=231 Participants
Participants with HER2+ LA/mBC were treated with tucatinib 300 mg orally BID and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs)
|
233 Participants
|
230 Participants
|
Adverse Events
Placebo+ Ado-trastuzumab Emtansine
Serious events: 52 serious events
Other events: 227 other events
Deaths: 63 deaths
Tucatinib+ Ado-trastuzumab Emtansine
Serious events: 70 serious events
Other events: 230 other events
Deaths: 71 deaths
Serious adverse events
| Measure |
Placebo+ Ado-trastuzumab Emtansine
n=233 participants at risk
Participants with HER2+ LA/mBC were treated with placebo orally BID, and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
|
Tucatinib+ Ado-trastuzumab Emtansine
n=231 participants at risk
Participants with HER2+ LA/mBC were treated with tucatinib 300 mg orally BID and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.87%
2/231 • Number of events 2 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
1.3%
3/231 • Number of events 3 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
1.3%
3/231 • Number of events 3 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.86%
2/233 • Number of events 2 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
1.3%
3/231 • Number of events 3 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
3/233 • Number of events 3 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
1.3%
3/231 • Number of events 3 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
General disorders
Chest pain
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
General disorders
Death
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
General disorders
Fatigue
|
1.3%
3/233 • Number of events 3 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
General disorders
Gait inability
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
General disorders
General physical health deterioration
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
General disorders
Influenza like illness
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
General disorders
Malaise
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
General disorders
Pyrexia
|
0.86%
2/233 • Number of events 2 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
1.3%
3/231 • Number of events 3 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.87%
2/231 • Number of events 3 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
1.3%
3/231 • Number of events 3 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.86%
2/233 • Number of events 2 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Infections and infestations
COVID-19
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.87%
2/231 • Number of events 2 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Infections and infestations
Cellulitis
|
0.43%
1/233 • Number of events 2 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 2 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Infections and infestations
Mastitis
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.87%
2/231 • Number of events 2 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
1.7%
4/233 • Number of events 4 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Infections and infestations
Progressive multifocal leukoencephalopathy
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Infections and infestations
Pyelonephritis acute
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Infections and infestations
Sepsis
|
1.7%
4/233 • Number of events 5 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
1.7%
4/231 • Number of events 4 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Infections and infestations
Tooth infection
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Infections and infestations
Urosepsis
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.87%
2/231 • Number of events 2 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Infections and infestations
Wound infection
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Splenic injury
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.87%
2/231 • Number of events 2 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Investigations
Ejection fraction decreased
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
3/233 • Number of events 3 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.43%
1/233 • Number of events 2 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.87%
2/231 • Number of events 2 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.43%
1/233 • Number of events 2 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Nervous system disorders
Ataxia
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Nervous system disorders
Brain oedema
|
0.86%
2/233 • Number of events 2 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.87%
2/231 • Number of events 2 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Nervous system disorders
Central nervous system necrosis
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.87%
2/231 • Number of events 2 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.43%
1/233 • Number of events 3 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Nervous system disorders
Hemiparesis
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Nervous system disorders
Hydrocephalus
|
0.86%
2/233 • Number of events 2 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Nervous system disorders
Seizure
|
1.3%
3/233 • Number of events 3 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
1.3%
3/231 • Number of events 4 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.87%
2/231 • Number of events 2 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Depression
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.86%
2/233 • Number of events 3 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
1.3%
3/231 • Number of events 3 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic paralysis
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
1.3%
3/231 • Number of events 3 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.86%
2/233 • Number of events 2 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.00%
0/231 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.43%
1/233 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/233 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
0.43%
1/231 • Number of events 1 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
Other adverse events
| Measure |
Placebo+ Ado-trastuzumab Emtansine
n=233 participants at risk
Participants with HER2+ LA/mBC were treated with placebo orally BID, and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
|
Tucatinib+ Ado-trastuzumab Emtansine
n=231 participants at risk
Participants with HER2+ LA/mBC were treated with tucatinib 300 mg orally BID and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.2%
26/233 • Number of events 35 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
19.0%
44/231 • Number of events 58 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.4%
29/233 • Number of events 33 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
16.0%
37/231 • Number of events 44 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Eye disorders
Dry eye
|
6.0%
14/233 • Number of events 14 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
10.4%
24/231 • Number of events 26 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Eye disorders
Vision blurred
|
9.9%
23/233 • Number of events 27 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
10.0%
23/231 • Number of events 25 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.0%
28/233 • Number of events 33 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
14.7%
34/231 • Number of events 40 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.0%
21/233 • Number of events 30 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
10.8%
25/231 • Number of events 33 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
33.0%
77/233 • Number of events 99 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
26.4%
61/231 • Number of events 76 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
26.6%
62/233 • Number of events 92 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
56.7%
131/231 • Number of events 217 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
13.3%
31/233 • Number of events 31 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
10.8%
25/231 • Number of events 25 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.9%
23/233 • Number of events 26 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
10.4%
24/231 • Number of events 28 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.7%
4/233 • Number of events 4 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
6.9%
16/231 • Number of events 17 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gingival bleeding
|
5.2%
12/233 • Number of events 13 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
3.0%
7/231 • Number of events 9 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
48.5%
113/233 • Number of events 152 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
65.4%
151/231 • Number of events 260 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
13.3%
31/233 • Number of events 41 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
6.9%
16/231 • Number of events 16 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
39/233 • Number of events 59 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
36.8%
85/231 • Number of events 153 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
General disorders
Asthenia
|
13.3%
31/233 • Number of events 55 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
12.1%
28/231 • Number of events 39 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
General disorders
Chills
|
5.2%
12/233 • Number of events 13 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
7.4%
17/231 • Number of events 26 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
General disorders
Fatigue
|
36.5%
85/233 • Number of events 115 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
48.9%
113/231 • Number of events 151 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
General disorders
Malaise
|
4.3%
10/233 • Number of events 22 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
5.2%
12/231 • Number of events 14 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
General disorders
Oedema peripheral
|
7.7%
18/233 • Number of events 22 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
8.7%
20/231 • Number of events 24 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
General disorders
Pain
|
2.1%
5/233 • Number of events 5 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
5.2%
12/231 • Number of events 15 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
General disorders
Pyrexia
|
14.2%
33/233 • Number of events 43 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
23.4%
54/231 • Number of events 94 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Infections and infestations
COVID-19
|
15.0%
35/233 • Number of events 39 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
16.0%
37/231 • Number of events 39 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
6.4%
15/233 • Number of events 16 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
4.3%
10/231 • Number of events 12 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.2%
12/233 • Number of events 13 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
3.5%
8/231 • Number of events 8 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
9.0%
21/233 • Number of events 27 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
12.6%
29/231 • Number of events 52 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
4.3%
10/233 • Number of events 10 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
6.9%
16/231 • Number of events 21 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
4.7%
11/233 • Number of events 13 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
6.5%
15/231 • Number of events 23 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.6%
6/233 • Number of events 7 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
6.5%
15/231 • Number of events 18 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
17.2%
40/233 • Number of events 56 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
33.8%
78/231 • Number of events 103 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
19.3%
45/233 • Number of events 61 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
35.9%
83/231 • Number of events 115 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
2.6%
6/233 • Number of events 7 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
5.2%
12/231 • Number of events 17 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Investigations
Blood bilirubin increased
|
6.0%
14/233 • Number of events 27 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
11.7%
27/231 • Number of events 72 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Investigations
Platelet count decreased
|
8.6%
20/233 • Number of events 27 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
10.8%
25/231 • Number of events 46 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Investigations
Weight decreased
|
6.0%
14/233 • Number of events 15 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
14.7%
34/231 • Number of events 34 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.7%
53/233 • Number of events 65 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
33.8%
78/231 • Number of events 99 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.4%
8/233 • Number of events 8 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
6.9%
16/231 • Number of events 18 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.7%
25/233 • Number of events 33 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
13.9%
32/231 • Number of events 39 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
4.7%
11/233 • Number of events 17 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
5.6%
13/231 • Number of events 18 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
27.0%
63/233 • Number of events 88 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
23.4%
54/231 • Number of events 75 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.0%
35/233 • Number of events 43 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
10.8%
25/231 • Number of events 26 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.4%
8/233 • Number of events 12 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
5.6%
13/231 • Number of events 15 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.3%
17/233 • Number of events 18 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
10.8%
25/231 • Number of events 28 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.9%
9/233 • Number of events 10 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
5.2%
12/231 • Number of events 12 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.2%
12/233 • Number of events 12 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
2.2%
5/231 • Number of events 5 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.4%
29/233 • Number of events 32 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
16.0%
37/231 • Number of events 37 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.4%
29/233 • Number of events 44 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
11.7%
27/231 • Number of events 33 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
12.9%
30/233 • Number of events 33 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
13.0%
30/231 • Number of events 32 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
6.0%
14/233 • Number of events 14 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
6.9%
16/231 • Number of events 20 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
38.6%
90/233 • Number of events 131 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
35.9%
83/231 • Number of events 120 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.2%
47/233 • Number of events 62 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
17.7%
41/231 • Number of events 43 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
5.6%
13/233 • Number of events 13 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
7.4%
17/231 • Number of events 17 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Depression
|
3.0%
7/233 • Number of events 7 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
5.2%
12/231 • Number of events 12 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
12.0%
28/233 • Number of events 30 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
12.1%
28/231 • Number of events 32 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.3%
38/233 • Number of events 48 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
16.5%
38/231 • Number of events 43 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.9%
23/233 • Number of events 27 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
10.8%
25/231 • Number of events 28 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
19.7%
46/233 • Number of events 63 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
34.2%
79/231 • Number of events 125 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.7%
18/233 • Number of events 18 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
10.0%
23/231 • Number of events 23 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.2%
19/233 • Number of events 21 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
7.8%
18/231 • Number of events 24 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.3%
17/233 • Number of events 23 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
13.9%
32/231 • Number of events 35 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
3.0%
7/233 • Number of events 7 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
5.2%
12/231 • Number of events 21 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.7%
18/233 • Number of events 23 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
10.0%
23/231 • Number of events 30 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypertension
|
3.4%
8/233 • Number of events 13 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
6.1%
14/231 • Number of events 17 • From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place