Trial Outcomes & Findings for Continued HER2 Suppression With Lapatinib Plus Trastuzumab Versus Trastuzumab Alone (NCT NCT00968968)
NCT ID: NCT00968968
Last Updated: 2019-06-10
Results Overview
Progression-free survival (PFS) with lapatinib plus trastuzumab versus trastuzumab alone. Progression-free survival (PFS) is defined as the time from randomization to the earliest date of disease progression (with radiological evidence) or death from any cause, or to last contact date up to 21Feb2014. Disease Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1), a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum diameters recorded since the treatment started (the sum must have an absolute increase from nadir of 5mm), or an unequivocal progression of existing non-target lesions, or the appearance of new lesions.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
37 participants
Primary outcome timeframe
Time from randomization until disease progression or death, approximately 4 years
Results posted on
2019-06-10
Participant Flow
A total of 37 subjects with HER2-positive metastatic breast cancer were enrolled.
Subjects enrolled in the study were randomized 1:1 to either of the arms.
Participant milestones
| Measure |
Lapatinib + Trastuzumab
Lapatinib 1000 mg oral once daily plus intravenous (iv) trastuzumab 6 mg/kg once every 3 weeks.
|
Trastuzumab
Trastuzumab iv 6 mg/kg once every 3 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
17
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
16
|
14
|
Reasons for withdrawal
| Measure |
Lapatinib + Trastuzumab
Lapatinib 1000 mg oral once daily plus intravenous (iv) trastuzumab 6 mg/kg once every 3 weeks.
|
Trastuzumab
Trastuzumab iv 6 mg/kg once every 3 weeks
|
|---|---|---|
|
Overall Study
Study closed/terminated
|
10
|
10
|
|
Overall Study
Protocol defined stopping criteria
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Continued HER2 Suppression With Lapatinib Plus Trastuzumab Versus Trastuzumab Alone
Baseline characteristics by cohort
| Measure |
Lapatinib + Trastuzumab
n=20 Participants
Lapatinib 1000 mg oral once daily plus intravenous (iv) trastuzumab 6 mg/kg once every 3 weeks.
|
Trastuzumab
n=17 Participants
Trastuzumab iv 6 mg/kg once every 3 weeks
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.3 years
STANDARD_DEVIATION 12.70 • n=5 Participants
|
59.1 years
STANDARD_DEVIATION 9.44 • n=7 Participants
|
56.5 years
STANDARD_DEVIATION 11.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time from randomization until disease progression or death, approximately 4 yearsPopulation: Intent-to-treat population: All randomized subjects and based on the treatment to which the subject was randomized.
Progression-free survival (PFS) with lapatinib plus trastuzumab versus trastuzumab alone. Progression-free survival (PFS) is defined as the time from randomization to the earliest date of disease progression (with radiological evidence) or death from any cause, or to last contact date up to 21Feb2014. Disease Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1), a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum diameters recorded since the treatment started (the sum must have an absolute increase from nadir of 5mm), or an unequivocal progression of existing non-target lesions, or the appearance of new lesions.
Outcome measures
| Measure |
Lapatinib + Trastuzumab
n=20 Participants
Lapatinib 1000 mg oral once daily plus intravenous (iv) trastuzumab 6 mg/kg once every 3 weeks.
|
Trastuzumab
n=17 Participants
Trastuzumab iv 6 mg/kg once every 3 weeks
|
|---|---|---|
|
Progression-free Survival
|
25 months
Interval 2.5 to 30.3
|
2 months
Interval 1.9 to 6.4
|
SECONDARY outcome
Timeframe: Time from randomization until death, approximately 4 yearsPopulation: Intent-to-treat population: All randomized subjects and based on the treatment to which the subject was randomized.
Overall Survival is defined as the interval of time (in months) between the date of randomization and the date of death due to any cause.
Outcome measures
| Measure |
Lapatinib + Trastuzumab
n=20 Participants
Lapatinib 1000 mg oral once daily plus intravenous (iv) trastuzumab 6 mg/kg once every 3 weeks.
|
Trastuzumab
n=17 Participants
Trastuzumab iv 6 mg/kg once every 3 weeks
|
|---|---|---|
|
Overall Survival
|
NA Months
Interval 36.5 to
Median and upper limit was not estimable due to few participants with events
|
NA Months
Interval 24.5 to
Median and upper limit was not estimable due to few participants with events
|
SECONDARY outcome
Timeframe: approximately 4 yearsPopulation: Intent-to-treat population: All randomized subjects and based on the treatment to which the subject was randomized
The best overall response was the best response from the start of the treatment until disease progression/recurrence and was determined programmatically using investigators assessment of responses of target lesion, non-target lesion and new lesions based on RECIST v1.1. Complete Response (CR) = disappearance of all target lesion and non-target lesions if applicable, and no new lesion; Partial Response (PR) = ≥30% decrease in the sum of the longest diameter of target lesions and non-target lesion was neither complete response nor progressive disease (Non-CR/Non-PD) or not evaluable (NE); SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD = ≥ 20% increase from nadir of the target lesions or appearance of new lesion. CR and PR were confirmed responses. Confirmed CR - at least two determinations of CR at least 4 weeks apart before PD; Confirmed PR - at least two determinations of PR or better at least 4 weeks apart before PD.
Outcome measures
| Measure |
Lapatinib + Trastuzumab
n=20 Participants
Lapatinib 1000 mg oral once daily plus intravenous (iv) trastuzumab 6 mg/kg once every 3 weeks.
|
Trastuzumab
n=17 Participants
Trastuzumab iv 6 mg/kg once every 3 weeks
|
|---|---|---|
|
Best Overall Response
Complete response (CR)
|
0 Participants
|
0 Participants
|
|
Best Overall Response
Partial response (PR)
|
2 Participants
|
0 Participants
|
|
Best Overall Response
Stable disease (SD)
|
1 Participants
|
2 Participants
|
|
Best Overall Response
Non - CR/Non - PD
|
4 Participants
|
3 Participants
|
|
Best Overall Response
Progressive disease (PD)
|
1 Participants
|
7 Participants
|
|
Best Overall Response
Not evaluable (NE)
|
12 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: approximately 4 yearsPopulation: Intent-to-treat population: All randomized subjects and based on the treatment to which the subject was randomized
Clinical Benefit Rate (CBR) was defined as the percentage of patients achieving either a confirmed CR or PR at any time or maintaining SD for at least 24 weeks while on study, according to the investigator assessment of response per RECIST 1.1 criteria. Confirmed CR - at least two determinations of CR at least 4 weeks apart before PD; Confirmed PR - at least two determinations of PR or better at least 4 weeks apart before PD.
Outcome measures
| Measure |
Lapatinib + Trastuzumab
n=20 Participants
Lapatinib 1000 mg oral once daily plus intravenous (iv) trastuzumab 6 mg/kg once every 3 weeks.
|
Trastuzumab
n=17 Participants
Trastuzumab iv 6 mg/kg once every 3 weeks
|
|---|---|---|
|
Clinical Benefit Response Rate (CR, PR or SD ≥24 Weeks)
|
10 Percentages of participants
Interval 1.2 to 31.7
|
0 Percentages of participants
Confidence interval cannot be calculated due to insufficient number of patients with events.
|
SECONDARY outcome
Timeframe: From first dose of study treatment until 30 days after the last dose of study treatment, approximately 8 years.Population: Safety population: All subjects who received any dose of lapatinib + trastuzumab or trastuzumab.
Outcome measures
| Measure |
Lapatinib + Trastuzumab
n=18 Participants
Lapatinib 1000 mg oral once daily plus intravenous (iv) trastuzumab 6 mg/kg once every 3 weeks.
|
Trastuzumab
n=16 Participants
Trastuzumab iv 6 mg/kg once every 3 weeks
|
|---|---|---|
|
Adverse Event Profile of the Two Treatment Arms
AE leading to dose reduction
|
0 Participants
|
0 Participants
|
|
Adverse Event Profile of the Two Treatment Arms
Any AEs
|
18 Participants
|
16 Participants
|
|
Adverse Event Profile of the Two Treatment Arms
AEs related to study treatment
|
16 Participants
|
7 Participants
|
|
Adverse Event Profile of the Two Treatment Arms
AEs leading to discont. of study treatment
|
3 Participants
|
0 Participants
|
|
Adverse Event Profile of the Two Treatment Arms
AE leading to dose interruption/delay
|
11 Participants
|
2 Participants
|
|
Adverse Event Profile of the Two Treatment Arms
Any SAE
|
7 Participants
|
4 Participants
|
|
Adverse Event Profile of the Two Treatment Arms
SAEs related to study treatment
|
3 Participants
|
1 Participants
|
|
Adverse Event Profile of the Two Treatment Arms
Fatal SAEs
|
0 Participants
|
0 Participants
|
|
Adverse Event Profile of the Two Treatment Arms
Fatal SAEs related to study treatment
|
0 Participants
|
0 Participants
|
Adverse Events
Lapatinib + Trastuzumab
Serious events: 7 serious events
Other events: 18 other events
Deaths: 0 deaths
Trastuzumab
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
All Subjects
Serious events: 11 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lapatinib + Trastuzumab
n=18 participants at risk
Lapatinib 1000 mg oral once daily plus intravenous (iv) trastuzumab 6 mg/kg once every 3 weeks.
|
Trastuzumab
n=17 participants at risk
Trastuzumab iv 6 mg/kg once every 3 weeks
|
All Subjects
n=35 participants at risk
All Subjects
|
|---|---|---|---|
|
Cardiac disorders
Pericardial effusion
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Endocrine disorders
Goitre
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Gastrointestinal disorders
Pancreatitis acute
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Gastrointestinal disorders
Volvulus
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Hepatobiliary disorders
Cholelithiasis
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Infections and infestations
Appendicitis
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Infections and infestations
Cellulitis
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
11.8%
2/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.7%
2/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Infections and infestations
Peritonsillar abscess
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Infections and infestations
Tonsillitis
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Investigations
Alanine aminotransferase increased
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Investigations
Aspartate aminotransferase increased
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
Other adverse events
| Measure |
Lapatinib + Trastuzumab
n=18 participants at risk
Lapatinib 1000 mg oral once daily plus intravenous (iv) trastuzumab 6 mg/kg once every 3 weeks.
|
Trastuzumab
n=17 participants at risk
Trastuzumab iv 6 mg/kg once every 3 weeks
|
All Subjects
n=35 participants at risk
All Subjects
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Cardiac disorders
Atrial fibrillation
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Cardiac disorders
Diastolic dysfunction
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Cardiac disorders
Left atrial enlargement
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Cardiac disorders
Pericardial effusion
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Cardiac disorders
Ventricular hypertrophy
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Ear and labyrinth disorders
Middle ear effusion
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Eye disorders
Blepharospasm
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Eye disorders
Eye irritation
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Eye disorders
Eye swelling
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Eye disorders
Lacrimation increased
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Eye disorders
Photopsia
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Eye disorders
Retinal detachment
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Eye disorders
Vision blurred
|
16.7%
3/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
8.6%
3/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Eye disorders
Visual impairment
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
3/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
8.6%
3/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
11.8%
2/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
8.6%
3/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Gastrointestinal disorders
Constipation
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.7%
2/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
83.3%
15/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
29.4%
5/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
57.1%
20/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
2/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.7%
2/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
2/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.7%
2/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
2/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.7%
2/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.1%
2/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
8.6%
3/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Gastrointestinal disorders
Gingival pain
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Gastrointestinal disorders
Mouth ulceration
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Gastrointestinal disorders
Nausea
|
66.7%
12/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
23.5%
4/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
45.7%
16/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Gastrointestinal disorders
Oral discomfort
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Gastrointestinal disorders
Oral pain
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Gastrointestinal disorders
Proctalgia
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
3/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
11.4%
4/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Gastrointestinal disorders
Tongue ulceration
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Gastrointestinal disorders
Vomiting
|
38.9%
7/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
17.6%
3/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
28.6%
10/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
General disorders
Asthenia
|
11.1%
2/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.7%
2/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
General disorders
Catheter site bruise
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
General disorders
Catheter site erythema
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
General disorders
Chills
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
General disorders
Fatigue
|
44.4%
8/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
25.7%
9/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
General disorders
Infusion site pain
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
General disorders
Non-cardiac chest pain
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
General disorders
Oedema peripheral
|
11.1%
2/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
8.6%
3/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
General disorders
Peripheral swelling
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.7%
2/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
General disorders
Pyrexia
|
22.2%
4/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
14.3%
5/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
General disorders
Ulcer
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Immune system disorders
Seasonal allergy
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
11.8%
2/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
8.6%
3/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Infections and infestations
Abscess limb
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Infections and infestations
Breast cellulitis
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Infections and infestations
Bronchitis
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.7%
2/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Infections and infestations
Cellulitis
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
17.6%
3/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
8.6%
3/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Infections and infestations
Clostridium difficile infection
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Infections and infestations
Ear infection
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.7%
2/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Infections and infestations
Herpes zoster
|
11.1%
2/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.7%
2/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Infections and infestations
Infection
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Infections and infestations
Influenza
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Infections and infestations
Laryngitis
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Infections and infestations
Localised infection
|
16.7%
3/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
8.6%
3/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
17.6%
3/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
11.4%
4/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Infections and infestations
Perineal abscess
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Infections and infestations
Pharyngitis
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Infections and infestations
Pharyngitis streptococcal
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Infections and infestations
Postoperative wound infection
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Infections and infestations
Rhinitis
|
11.1%
2/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.7%
2/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Infections and infestations
Sepsis
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Infections and infestations
Sinusitis
|
11.1%
2/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
11.8%
2/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
11.4%
4/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Infections and infestations
Skin infection
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
3/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
17.6%
3/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
17.1%
6/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Infections and infestations
Urinary tract infection
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
11.8%
2/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
8.6%
3/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Injury, poisoning and procedural complications
Incision site swelling
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Injury, poisoning and procedural complications
Laceration
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Injury, poisoning and procedural complications
Muscle strain
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Injury, poisoning and procedural complications
Procedural pain
|
11.1%
2/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
8.6%
3/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
2/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
8.6%
3/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Investigations
Aspartate aminotransferase increased
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.7%
2/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Investigations
Blood alkaline phosphatase increased
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Investigations
Blood glucose increased
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Investigations
Blood urea increased
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Investigations
Ejection fraction decreased
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Investigations
Haemoglobin decreased
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Investigations
Immunoglobulins decreased
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Investigations
Neutrophil count decreased
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Investigations
Neutrophil count increased
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Investigations
Weight decreased
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.7%
2/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Investigations
White blood cell count decreased
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Investigations
White blood cell count increased
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
3/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
8.6%
3/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.7%
2/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
22.2%
4/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
11.4%
4/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
16.7%
3/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
8.6%
3/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
2/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
17.6%
3/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
14.3%
5/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
2/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.7%
2/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.1%
2/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
23.5%
4/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
17.1%
6/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
11.1%
2/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
11.8%
2/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
11.4%
4/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
22.2%
4/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
14.3%
5/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
3/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
8.6%
3/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
22.2%
4/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
11.8%
2/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
17.1%
6/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroma
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Nervous system disorders
Dizziness
|
16.7%
3/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
8.6%
3/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Nervous system disorders
Dysgeusia
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Nervous system disorders
Headache
|
22.2%
4/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
11.4%
4/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Nervous system disorders
Hypoaesthesia
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.7%
2/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Nervous system disorders
Hypokinesia
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Nervous system disorders
Loss of consciousness
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Nervous system disorders
Memory impairment
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Nervous system disorders
Paraesthesia
|
16.7%
3/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
8.6%
3/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Psychiatric disorders
Confusional state
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Psychiatric disorders
Depression
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.7%
2/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Psychiatric disorders
Insomnia
|
16.7%
3/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
11.8%
2/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
14.3%
5/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Renal and urinary disorders
Dysuria
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Renal and urinary disorders
Pollakiuria
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.7%
2/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
11.8%
2/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.7%
2/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Reproductive system and breast disorders
Genital rash
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
17.6%
3/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
11.4%
4/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
38.9%
7/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
20.0%
7/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.1%
2/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
11.8%
2/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
11.4%
4/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cyst
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
3/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
8.6%
3/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
2/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.7%
2/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.7%
2/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
3/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
8.6%
3/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
22.2%
4/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
11.4%
4/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
11.1%
2/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.7%
2/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
3/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
17.6%
3/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
17.1%
6/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
55.6%
10/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
23.5%
4/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
40.0%
14/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Scab
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Vascular disorders
Aortic arteriosclerosis
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Vascular disorders
Hot flush
|
16.7%
3/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
5.9%
1/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
11.4%
4/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Vascular disorders
Hypertension
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
|
Vascular disorders
Hypotension
|
5.6%
1/18 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
0.00%
0/17 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
2.9%
1/35 • Adverse Events and Serious Adverse Events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 8.5 years.
From first dose of study treatment until 30 days after the last dose of study treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER