Trial Outcomes & Findings for LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib (NCT NCT01828112)
NCT ID: NCT01828112
Last Updated: 2025-02-07
Results Overview
PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
231 participants
Primary outcome timeframe
From the date of randomization to the date of first radiologically documented disease progression or death due to any cause up to approximately 24 months
Results posted on
2025-02-07
Participant Flow
Participants were enrolled in the following countries (with number of sites): Belgium (4), Canada (1), France (9), Germany (8), Hong Kong (3), Ireland (2), Israel (2), Italy (10), Japan (12), Republic of Korea (5), Lebanon (1), Netherlands (2), Portugal (1), Russia (3), Singapore (2), Spain (11), Switzerland (2), Turkey (3), United Kingdom (5), United States (13).
In the treatment phase, patients were randomized 1:1 to one of the treatment arms (ceritinib or chemotherapy). In the extension treatment phase, only patients randomized to the chemotherapy arm were allowed to crossover to receive ceritinib therapy after BIRC-confirmed, RECIST-defined disease progression.
Participant milestones
| Measure |
Ceritinib
Ceritinib 750 mg
|
Chemotherapy
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
Treatment Phase
STARTED
|
115
|
116
|
0
|
|
Treatment Phase
Safety Set
|
115
|
113
|
0
|
|
Treatment Phase
COMPLETED
|
0
|
0
|
0
|
|
Treatment Phase
NOT COMPLETED
|
115
|
116
|
0
|
|
Extension Treatment Phase
STARTED
|
0
|
0
|
79
|
|
Extension Treatment Phase
Crossover Analysis Set
|
0
|
0
|
78
|
|
Extension Treatment Phase
COMPLETED
|
0
|
0
|
0
|
|
Extension Treatment Phase
NOT COMPLETED
|
0
|
0
|
79
|
Reasons for withdrawal
| Measure |
Ceritinib
Ceritinib 750 mg
|
Chemotherapy
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
Treatment Phase
Adverse Event
|
7
|
8
|
0
|
|
Treatment Phase
Death
|
9
|
5
|
0
|
|
Treatment Phase
No longer required treatment
|
0
|
1
|
0
|
|
Treatment Phase
Physician Decision
|
6
|
7
|
0
|
|
Treatment Phase
Pregnancy
|
1
|
0
|
0
|
|
Treatment Phase
Progressive disease
|
79
|
87
|
0
|
|
Treatment Phase
Study terminated by sponsor
|
1
|
0
|
0
|
|
Treatment Phase
Subject/guardian decision
|
12
|
8
|
0
|
|
Extension Treatment Phase
Adverse Event
|
0
|
0
|
6
|
|
Extension Treatment Phase
Death
|
0
|
0
|
17
|
|
Extension Treatment Phase
Physician Decision
|
0
|
0
|
5
|
|
Extension Treatment Phase
Progressive disease
|
0
|
0
|
46
|
|
Extension Treatment Phase
Study terminated by sponsor
|
0
|
0
|
1
|
|
Extension Treatment Phase
Subject/guardian decision
|
0
|
0
|
4
|
Baseline Characteristics
LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib
Baseline characteristics by cohort
| Measure |
Ceritinib
n=115 Participants
Ceritinib 750 mg
|
Chemotherapy
n=116 Participants
Chemotherapy as determined by BIRC
|
Total
n=231 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.1 Years
STANDARD_DEVIATION 11.96 • n=5 Participants
|
54.4 Years
STANDARD_DEVIATION 11.61 • n=7 Participants
|
53.7 Years
STANDARD_DEVIATION 11.78 • n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
30 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
81 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization to the date of first radiologically documented disease progression or death due to any cause up to approximately 24 monthsPopulation: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.
Outcome measures
| Measure |
Ceritinib
n=115 Participants
Ceritinib 750 mg
|
Chemotherapy
n=116 Participants
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
Progression Free Survival (PFS) Per Blinded Independent Review Committee (BIRC)
|
5.4 months
Interval 4.1 to 6.9
|
1.6 months
Interval 1.4 to 2.8
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 114 monthsPopulation: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
OS was defined as time from date of randomization to date of death due to any cause.
Outcome measures
| Measure |
Ceritinib
n=115 Participants
Ceritinib 750 mg
|
Chemotherapy
n=116 Participants
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
Overall Survival (OS)
|
17.7 months
Interval 14.2 to 23.7
|
20.1 months
Interval 11.9 to 31.2
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 84 monthsPopulation: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.
Outcome measures
| Measure |
Ceritinib
n=115 Participants
Ceritinib 750 mg
|
Chemotherapy
n=116 Participants
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
Progression Free Survival (PFS) Per Investigator Assessment
|
6.2 months
Interval 4.4 to 7.9
|
1.6 months
Interval 1.4 to 2.6
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 54 monthsPopulation: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
ORR was defined as the percentage of participants with a best overall response defined as complete response (CR) or partial response (PR): (CR+PR) per Response Evaluation Criteria in Solid Tumors (RECIST), v. 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Ceritinib
n=115 Participants
Ceritinib 750 mg
|
Chemotherapy
n=116 Participants
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
Overall Response Rate (ORR) Per BIRC
|
40.9 percentage of participants
Interval 31.8 to 50.4
|
6.9 percentage of participants
Interval 3.0 to 13.1
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 93 monthsPopulation: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
ORR was defined as the percentage of participants with a best overall response defined as complete response (CR) or partial response (PR): (CR+PR) per Response Evaluation Criteria in Solid Tumors (RECIST), v. 1.1. CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Ceritinib
n=115 Participants
Ceritinib 750 mg
|
Chemotherapy
n=116 Participants
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
Overall Response Rate (ORR) Per Investigator Assessment
|
44.3 percentage of participants
Interval 35.1 to 53.9
|
6.9 percentage of participants
Interval 3.0 to 13.1
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 54 monthsPopulation: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Patients with confirmed CR or PR.
DOR defined as the time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer. CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Ceritinib
n=47 Participants
Ceritinib 750 mg
|
Chemotherapy
n=8 Participants
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
Duration of Response (DOR) Per BIRC
|
7.6 months
Interval 5.4 to 8.3
|
10.4 months
Interval 3.5 to
The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 93 monthsPopulation: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Data are reported for responders only. Patients with confirmed CR or PR.
DOR defined as the time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer. CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Ceritinib
n=51 Participants
Ceritinib 750 mg
|
Chemotherapy
n=8 Participants
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
Duration of Response (DOR) Per Investigator Assessment
|
6.7 months
Interval 5.5 to 8.3
|
8.3 months
Interval 2.8 to 69.9
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 54 monthsPopulation: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
DCR was defined as the percentage of participants with best overall response of CR, PR, or stable disease (SD). CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
Outcome measures
| Measure |
Ceritinib
n=115 Participants
Ceritinib 750 mg
|
Chemotherapy
n=116 Participants
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
Disease Control Rate (DCR) Per BIRC
|
76.5 percentage of participants
Interval 67.7 to 83.9
|
37.9 percentage of participants
Interval 29.1 to 47.4
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 93 monthsPopulation: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
DCR was defined as the percentage of participants with best overall response of CR, PR, or stable disease (SD). CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
Outcome measures
| Measure |
Ceritinib
n=115 Participants
Ceritinib 750 mg
|
Chemotherapy
n=116 Participants
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
Disease Control Rate (DCR) Per Investigator Assessment
|
80.0 percentage of participants
Interval 71.5 to 86.9
|
39.7 percentage of participants
Interval 30.7 to 49.2
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 52 weeksPopulation: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Patients with confirmed CR or PR.
TTR was defined as the time from date of randomization to date of first documented response (CR or PR). CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Ceritinib
n=47 Participants
Ceritinib 750 mg
|
Chemotherapy
n=8 Participants
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
Time to Response (TTR) Per BIRC
|
6.71 weeks
Interval 4.9 to 52.3
|
9.64 weeks
Interval 5.4 to 43.3
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 45 weeksPopulation: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Patients with confirmed CR or PR.
TTR was defined as the time from date of randomization to date of first documented response (CR or PR). CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Ceritinib
n=47 Participants
Ceritinib 750 mg
|
Chemotherapy
n=8 Participants
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
Time to Response (TTR) Per Investigator Assessment
|
6.43 weeks
Interval 4.9 to 45.4
|
14.71 weeks
Interval 6.3 to 36.4
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 18 monthsPopulation: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Patients with measurable and/or nonmeasurable disease in the brain at baseline as per BIRC neuroradiology review.
OIRR was defined as the ORR based on lesions in brain (target, nontarget lesions (and new lesions, if applicable) and calculated as the percentage of patients with a best overall confirmed response of CR or PR in the brain per modified RECIST 1.1 as assessed by BIRC neuroradiologist. CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Ceritinib
n=66 Participants
Ceritinib 750 mg
|
Chemotherapy
n=67 Participants
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
Overall Intracranial Response Rate (OIRR) Per BIRC
|
10.6 percentage of participants
Interval 4.4 to 20.6
|
3.0 percentage of participants
Interval 0.4 to 10.4
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 18 monthsPopulation: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Patients with measurable and/or nonmeasurable disease in the brain at baseline as per BIRC neuroradiology review.
IDCR was defined as the DCR based on lesions in brain (target, non-target lesions (and new lesions, if applicable) and calculated as the proportion of patients with a best overall response of CR or PR or SD (or non-CR/nonPD) in the brain per modified RECIST 1.1 as assessed by BIRC neuro-radiologist. CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
Outcome measures
| Measure |
Ceritinib
n=66 Participants
Ceritinib 750 mg
|
Chemotherapy
n=67 Participants
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
Intracranial Disease Control Rate (IDCR) Per BIRC
|
71.2 percentage of participants
Interval 58.7 to 81.7
|
53.7 percentage of participants
Interval 41.1 to 66.0
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 18 monthsPopulation: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Patients with measurable and/or nonmeasurable disease in the brain at baseline as per BIRC neuroradiology review. patients with measurable and/or non-measurable disease in the brain at baseline as per BIRC neuro-radiology review, and with confirmed intracranial CR or PR.
DOIR was defined as the DOR based on lesions in brain (target, non-target lesions (and new lesions, if applicable) and calculated from the time of first documented response of CR or PR to the date of the first documented disease progression in the brain or death due to any cause per modified RECIST 1.1 as assessed by BIRC neuro-radiologist. CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Ceritinib
n=6 Participants
Ceritinib 750 mg
|
Chemotherapy
n=1 Participants
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
Duration of Intracranial Response (DOIR) Per BIRC
|
8.3 months
Interval 2.7 to
The upper limit of 95% CI was not estimable due to an insufficient number of participants with events.
|
16.7 months
The lower and upper limits of 95% CI were not estimable due to the single data point.
|
—
|
SECONDARY outcome
Timeframe: Screening and treatment phase up to 92 monthsPopulation: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
The EORTC QLQ-C30 questionnaire contained 30 items and was composed of both multi-item scales and single item measures. These included five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact), and a global health status/quality of life (QoL) scale. All of the scales and single items ranged from 0 to 100. A high scale score represented a higher response level. Thus, a high score for a functional scale indicated a high/healthy level of functioning, a high score for the QoL indicated high QoL, but a high score for a symptom scale/single item indicated a high level of symptomatology/problems. Data from all collected time points were combined and presented using a repeated measures model for longitudinal data.
Outcome measures
| Measure |
Ceritinib
n=107 Participants
Ceritinib 750 mg
|
Chemotherapy
n=86 Participants
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
Least Squares Mean Scores on the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC-QLQC30)
Global Health Status/QoL n=106,85
|
62.9 score on a scale
Standard Error 1.13
|
63.2 score on a scale
Standard Error 1.74
|
—
|
|
Least Squares Mean Scores on the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC-QLQC30)
Physical Functioning n=107,86
|
80.5 score on a scale
Standard Error 1.04
|
75.4 score on a scale
Standard Error 1.52
|
—
|
|
Least Squares Mean Scores on the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC-QLQC30)
Emotional Functioning n=106,86
|
82.4 score on a scale
Standard Error 1.01
|
80.7 score on a scale
Standard Error 1.54
|
—
|
|
Least Squares Mean Scores on the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC-QLQC30)
Social Functioning n=106,86
|
76.7 score on a scale
Standard Error 1.56
|
71.6 score on a scale
Standard Error 2.31
|
—
|
|
Least Squares Mean Scores on the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC-QLQC30)
Cognitive Functioning n=106,86
|
86.7 score on a scale
Standard Error 0.91
|
84.5 score on a scale
Standard Error 1.40
|
—
|
|
Least Squares Mean Scores on the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC-QLQC30)
Role Functioning n=107,86
|
72.6 score on a scale
Standard Error 1.30
|
68.7 score on a scale
Standard Error 1.98
|
—
|
|
Least Squares Mean Scores on the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC-QLQC30)
Fatigue n=107,86
|
31.1 score on a scale
Standard Error 1.10
|
36.1 score on a scale
Standard Error 1.69
|
—
|
|
Least Squares Mean Scores on the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC-QLQC30)
Nausea and Vomiting n=107,86
|
17.2 score on a scale
Standard Error 1.08
|
9.4 score on a scale
Standard Error 1.69
|
—
|
|
Least Squares Mean Scores on the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC-QLQC30)
Pain n=107,86
|
21.4 score on a scale
Standard Error 1.22
|
24.2 score on a scale
Standard Error 1.85
|
—
|
|
Least Squares Mean Scores on the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC-QLQC30)
Dyspnea n=107,86
|
17.4 score on a scale
Standard Error 1.03
|
24.0 score on a scale
Standard Error 1.62
|
—
|
|
Least Squares Mean Scores on the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC-QLQC30)
Insomnia n=107,86
|
18.9 score on a scale
Standard Error 1.33
|
25.6 score on a scale
Standard Error 2.05
|
—
|
|
Least Squares Mean Scores on the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC-QLQC30)
Appetite Loss n=107,86
|
21.2 score on a scale
Standard Error 1.33
|
13.9 score on a scale
Standard Error 2.07
|
—
|
|
Least Squares Mean Scores on the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC-QLQC30)
Constipation n=107,86
|
15.0 score on a scale
Standard Error 1.31
|
15.0 score on a scale
Standard Error 2.00
|
—
|
|
Least Squares Mean Scores on the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC-QLQC30)
Diarrhea n=106,86
|
29.3 score on a scale
Standard Error 1.29
|
11.4 score on a scale
Standard Error 2.02
|
—
|
|
Least Squares Mean Scores on the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC-QLQC30)
Financial Difficulties n=104,85
|
15.5 score on a scale
Standard Error 1.41
|
19.7 score on a scale
Standard Error 2.10
|
—
|
SECONDARY outcome
Timeframe: Screening and treatment phase up to 92 monthsPopulation: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
The Lung Cancer module of the EORTC's quality of life questionnaire (EORTC QLQ-LC13) was used in conjunction with the EORTC QLQ-C30 and provided information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporated one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores ranged from 0 to 100. A high score indicated a high level of symptoms. QLQ-LC13 time to definitive deterioration was defined as the time from randomization to the earliest date a patient shows a 10 point or higher increase from baseline in any of the ALCLC13 scores related to pain in chest, cough, or dyspnea (with no later change below this threshold), or death due to any cause. Each cycle was 21 days.
Outcome measures
| Measure |
Ceritinib
n=115 Participants
Ceritinib 750 mg
|
Chemotherapy
n=116 Participants
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
EORTC QLQ-LC13 Time to Definitive Deterioration
|
13.4 months
Interval 8.4 to 16.7
|
2.8 months
Interval 1.0 to 5.6
|
—
|
SECONDARY outcome
Timeframe: Screening and treatment phase up to 92 monthsPopulation: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
The LCSS patient scale uses a 24-hour recall period and contains nine items: six measuring major symptoms for lung cancer (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain), and three summary items related to total symptom distress, normal activity status, and overall quality of life. The total scale used is a 100 mm visual analog scale to measure the intensity of patient responses, with zero corresponding to the lowest rating (best status) and 100 representing the highest rating (worst status). The total score was calculated as the mean of the 9 items. Data from all collected time points were combined and presented using a repeated measures model for longitudinal data.
Outcome measures
| Measure |
Ceritinib
n=107 Participants
Ceritinib 750 mg
|
Chemotherapy
n=85 Participants
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
Least Squares Mean Scores on the Lung Cancer Symptom Scale (LCSS)
Pain n=107,85
|
18.2 millimeters
Standard Error 1.25
|
24.3 millimeters
Standard Error 1.92
|
—
|
|
Least Squares Mean Scores on the Lung Cancer Symptom Scale (LCSS)
LCSS Total Score n=106,82
|
22.0 millimeters
Standard Error 0.87
|
26.3 millimeters
Standard Error 1.33
|
—
|
|
Least Squares Mean Scores on the Lung Cancer Symptom Scale (LCSS)
Appetite Loss n=107,85
|
28.0 millimeters
Standard Error 1.26
|
26.6 millimeters
Standard Error 1.99
|
—
|
|
Least Squares Mean Scores on the Lung Cancer Symptom Scale (LCSS)
Fatigue n=107,84
|
34.6 millimeters
Standard Error 1.33
|
39.2 millimeters
Standard Error 2.06
|
—
|
|
Least Squares Mean Scores on the Lung Cancer Symptom Scale (LCSS)
Cough n=107,84
|
11.5 millimeters
Standard Error 1.01
|
18.4 millimeters
Standard Error 1.56
|
—
|
|
Least Squares Mean Scores on the Lung Cancer Symptom Scale (LCSS)
Shortness of Breath n=107,85
|
18.2 millimeters
Standard Error 0.99
|
24.8 millimeters
Standard Error 1.56
|
—
|
|
Least Squares Mean Scores on the Lung Cancer Symptom Scale (LCSS)
Hemoptysis n=107,85
|
1.8 millimeters
Standard Error 0.34
|
2.2 millimeters
Standard Error 0.55
|
—
|
|
Least Squares Mean Scores on the Lung Cancer Symptom Scale (LCSS)
Total Symptom Distress n=107,85
|
20.7 millimeters
Standard Error 1.26
|
24.6 millimeters
Standard Error 1.92
|
—
|
|
Least Squares Mean Scores on the Lung Cancer Symptom Scale (LCSS)
Normal Activity Status n=107,85
|
31.3 millimeters
Standard Error 1.47
|
36.8 millimeters
Standard Error 2.21
|
—
|
|
Least Squares Mean Scores on the Lung Cancer Symptom Scale (LCSS)
Overall Quality of Life n=106,84
|
33.1 millimeters
Standard Error 1.27
|
36.4 millimeters
Standard Error 1.94
|
—
|
|
Least Squares Mean Scores on the Lung Cancer Symptom Scale (LCSS)
LCSS Average Symptom Burden Index n=107,83
|
18.8 millimeters
Standard Error 0.77
|
22.9 millimeters
Standard Error 1.20
|
—
|
SECONDARY outcome
Timeframe: Screening and treatment phase up to 92 monthsPopulation: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
The EQ-5D descriptive classification consists of five dimensions of health: mobility, self-care, usual activities, anxiety/depression and pain/discomfort. Patients are requested to select the statement which best describes their condition on that day for each dimension. EQ-5D-5L index scores can range from -0.59 to 1, where 1 is the best possible health state. Data from all collected time points were combined and presented using a repeated measures model for longitudinal data.
Outcome measures
| Measure |
Ceritinib
n=107 Participants
Ceritinib 750 mg
|
Chemotherapy
n=88 Participants
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
Least Squares Mean Scores on the EQ-5D-5L Index
|
0.7837 score on a scale
Standard Error 0.01039
|
0.7108 score on a scale
Standard Error 0.01533
|
—
|
SECONDARY outcome
Timeframe: Screening and treatment phase up to 92 monthsPopulation: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
The EQ-5D descriptive classification consists of five dimensions of health: mobility, self-care, usual activities, anxiety/depression and pain/discomfort. Patients are requested to select the statement which best describes their condition on that day for each dimension. EQ VAS scores can range from 0 to 100, where 100 is the best possible health state. Data from all collected time points were combined and presented using a repeated measures model for longitudinal data.
Outcome measures
| Measure |
Ceritinib
n=106 Participants
Ceritinib 750 mg
|
Chemotherapy
n=86 Participants
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
Least Squares Mean Scores on the EQ-5D Visual Analogue Scale (VAS)
|
71.8 score on a scale
Standard Error 0.98
|
69.0 score on a scale
Standard Error 1.45
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 and Cycle 2, Day 1: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose. Each cycle was 21 days.Population: Participants in the pharmacokinetic (PK) analysis set who had extensive PK collection.
The observed maximum plasma concentration following administration
Outcome measures
| Measure |
Ceritinib
n=4 Participants
Ceritinib 750 mg
|
Chemotherapy
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
Cmax for Ceritinib
Cycle 1, Day 1 n=4,0
|
90.4 ng/mL
Geometric Coefficient of Variation 49.8
|
—
|
—
|
|
Cmax for Ceritinib
Cycle 2, Day 1 n=2,0
|
1170 ng/mL
Geometric Coefficient of Variation 17.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 and Cycle 2, Day 1: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose. Each cycle was 21 days.Population: Participants in the pharmacokinetic (PK) analysis set who had extensive PK collection.
The time to reach peak or maximum concentration
Outcome measures
| Measure |
Ceritinib
n=4 Participants
Ceritinib 750 mg
|
Chemotherapy
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
Tmax for Ceritinib
Cycle 1, Day 1 n=4,0
|
6.03 hours
Interval 4.17 to 23.6
|
—
|
—
|
|
Tmax for Ceritinib
Cycle 2, Day 1 n=2,0
|
7.15 hours
Interval 6.17 to 8.13
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 and Cycle 2, Day 1: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose. Each cycle was 21 days.Population: Participants in the pharmacokinetic (PK) analysis set who had extensive PK collection.
The time to last quantifiable concentration
Outcome measures
| Measure |
Ceritinib
n=4 Participants
Ceritinib 750 mg
|
Chemotherapy
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
Tlast for Ceritinib
Cycle 1, Day 1 n=4,0
|
24 hours
Interval 23.6 to 24.1
|
—
|
—
|
|
Tlast for Ceritinib
Cycle 2, Day 1 n=2,0
|
23.9 hours
Interval 23.7 to 24.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 and Cycle 2, Day 1: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose. Each cycle was 21 days.Population: Participants in the pharmacokinetic (PK) analysis set who had extensive PK collection.
The area under the plasma concentration-time curve calculated from time zero to 24 hours
Outcome measures
| Measure |
Ceritinib
n=4 Participants
Ceritinib 750 mg
|
Chemotherapy
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
AUC0-24h for Ceritinib
Cycle 1, Day 1 n=4,0
|
1470 h*ng/mL
Geometric Coefficient of Variation 65.1
|
—
|
—
|
|
AUC0-24h for Ceritinib
Cycle 2, Day 1 n=2,0
|
25000 h*ng/mL
Geometric Coefficient of Variation 19.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 and Cycle 2, Day 1: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose. Each cycle was 21 days.Population: Participants in the pharmacokinetic (PK) analysis set who had extensive PK collection.
Accumulation ratio calculated using AUC0-24 values obtained from a dosing interval at steady-state (Cycle 2, Day 1) divided by AUC0-24 on Cycle 1, Day 1.
Outcome measures
| Measure |
Ceritinib
n=1 Participants
Ceritinib 750 mg
|
Chemotherapy
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
Mean Accumulation Ratio (Racc) for Ceritinib
Cycle 2, Day 1 n=1,0
|
15.5 ratio
Geometric Coefficient of Variation NA
The geometric coefficient of variation was not estimable due to the single data point.
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 and Cycle 2, Day 1: pre-dose and 1, 2, 4, 6, 8, and 24 hours post-dose. Each cycle was 21 days.Population: Participants in the pharmacokinetic (PK) analysis set who had extensive PK collection.
The apparent total body clearance from plasma. CLss/F is calculated from AUC0-24 assuming steady state (CLss/F=Dose/AUC0-24).
Outcome measures
| Measure |
Ceritinib
n=2 Participants
Ceritinib 750 mg
|
Chemotherapy
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
Clearance Rate at Steady State (CLss/F) for Ceritinib
Cycle 2, Day 1 n=2,0
|
30 L/h
Geometric Coefficient of Variation 19.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-treatment and on-treatment deaths: Up to approximately 8 years. Post-treatment survival follow-up deaths: Up to an additional 2.5 years.Population: The analysis included patients who received at least one dose of study drug. For the Chemotherapy/Ceritinib group, the analysis included patients randomized to the chemotherapy arm who crossed over to receive at least one dose of ceritinib in the extension-treatment phase. For pre-treatment deaths, all randomized patients are included.
Pre-treatment deaths: from day of patient's informed consent to the day before first dose of study treatment. On-treatment deaths: from first dose of study treatment to 30 days following the last dose of study treatment at the end of treatment phase. For crossover patients, from first dose of ceritinib at the extension treatment phase to 30 days following the last dose. Survival Follow-up deaths: from Day 31 after last dose of study treatment to the data cut-off date.
Outcome measures
| Measure |
Ceritinib
n=115 Participants
Ceritinib 750 mg
|
Chemotherapy
n=116 Participants
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib
n=78 Participants
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|
|
Post-Hoc: All Collected Deaths
Pre-treatment deaths
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Post-Hoc: All Collected Deaths
On-treatment deaths
|
16 Participants
|
5 Participants
|
19 Participants
|
|
Post-Hoc: All Collected Deaths
Survival follow-up deaths
|
86 Participants
|
18 Participants
|
44 Participants
|
|
Post-Hoc: All Collected Deaths
All deaths
|
102 Participants
|
25 Participants
|
63 Participants
|
Adverse Events
Ceritinib (Pre-treatment)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Chemotherapy (Pre-treatment)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Chemotherapy/Ceritinib (Pre-treatment)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ceritinib (On-treatment)
Serious events: 57 serious events
Other events: 114 other events
Deaths: 16 deaths
Chemotherapy (On-treatment)
Serious events: 35 serious events
Other events: 111 other events
Deaths: 5 deaths
Chemotherapy/Ceritinib (On-treatment)
Serious events: 45 serious events
Other events: 76 other events
Deaths: 19 deaths
Ceritinib (Survival Follow-up)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 86 deaths
Chemotherapy (Survival Follow-up)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 18 deaths
Chemotherapy/Ceritinib (Survival Follow-up)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 44 deaths
Serious adverse events
| Measure |
Ceritinib (Pre-treatment)
Ceritinib 750 mg
|
Chemotherapy (Pre-treatment)
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib (Pre-treatment)
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
Ceritinib (On-treatment)
n=115 participants at risk
Ceritinib 750 mg
|
Chemotherapy (On-treatment)
n=113 participants at risk
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib (On-treatment)
n=78 participants at risk
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
Ceritinib (Survival Follow-up)
Ceritinib 750 mg
|
Chemotherapy (Survival Follow-up)
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib (Survival Follow-up)
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Cardiac disorders
Acute coronary syndrome
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Cardiac disorders
Atrial fibrillation
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.7%
2/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Cardiac disorders
Atrial flutter
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Cardiac disorders
Cardiac arrest
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Cardiac disorders
Myocardial ischaemia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Cardiac disorders
Pericardial effusion
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
3.5%
4/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Cardiac disorders
Pericarditis
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Cardiac disorders
Ventricular extrasystoles
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Eye disorders
Lenticular opacities
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Eye disorders
Visual field defect
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Gastrointestinal disorders
Abdominal pain
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Gastrointestinal disorders
Colitis
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Gastrointestinal disorders
Diarrhoea
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.7%
2/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Gastrointestinal disorders
Dysphagia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Gastrointestinal disorders
Faecaloma
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Gastrointestinal disorders
Gastric perforation
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Gastrointestinal disorders
Gastritis
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Gastrointestinal disorders
Haematemesis
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Gastrointestinal disorders
Large intestine perforation
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Gastrointestinal disorders
Nausea
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
7.0%
8/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
5.1%
4/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Gastrointestinal disorders
Vomiting
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
5.2%
6/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
6.4%
5/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
General disorders
Asthenia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.7%
2/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
2.7%
3/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
2.6%
2/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
General disorders
Chest pain
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
General disorders
Condition aggravated
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
General disorders
Fatigue
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.7%
2/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
General disorders
General physical health deterioration
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
6.1%
7/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.8%
2/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
General disorders
Multiple organ dysfunction syndrome
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
General disorders
Non-cardiac chest pain
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.7%
2/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
3.8%
3/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
General disorders
Pain
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
General disorders
Pyrexia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
3.5%
4/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.8%
2/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
General disorders
Sudden death
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Hepatobiliary disorders
Hepatic failure
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Hepatobiliary disorders
Hepatic lesion
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Hepatobiliary disorders
Jaundice
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Bacteraemia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Bacterial pyelonephritis
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Biliary tract infection
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Bronchitis
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Hepatic infection
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Infection
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Localised infection
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Lower respiratory tract infection
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Mucosal infection
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Nasopharyngitis
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Neutropenic sepsis
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.8%
2/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Oral herpes
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Pneumonia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
5.2%
6/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
3.5%
4/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
7.7%
6/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Pseudomembranous colitis
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Respiratory tract infection
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
2.6%
3/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Typhoid fever
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Upper respiratory tract infection
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Urinary tract infection
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Urosepsis
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Viral infection
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Investigations
Alanine aminotransferase increased
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Investigations
Aspartate aminotransferase increased
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Investigations
C-reactive protein increased
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Investigations
Electrocardiogram QT prolonged
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Investigations
Electrocardiogram T wave inversion
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Investigations
Neutrophil count decreased
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Metabolism and nutrition disorders
Dehydration
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.7%
2/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
3.8%
3/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.8%
2/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.7%
2/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
2.6%
2/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Nervous system disorders
Aphasia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Nervous system disorders
Brain oedema
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Nervous system disorders
Cerebellar infarction
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Nervous system disorders
Cerebrovascular accident
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Nervous system disorders
Cognitive disorder
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Nervous system disorders
Coordination abnormal
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Nervous system disorders
Depressed level of consciousness
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Nervous system disorders
Dizziness
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Nervous system disorders
Epilepsy
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.7%
2/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Nervous system disorders
Headache
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Nervous system disorders
Intracranial mass
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Nervous system disorders
Loss of consciousness
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Nervous system disorders
Paraesthesia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Nervous system disorders
Paraparesis
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Nervous system disorders
Parkinsonism
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Nervous system disorders
Partial seizures
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Nervous system disorders
Petit mal epilepsy
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Nervous system disorders
Presyncope
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Nervous system disorders
Seizure
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.8%
2/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
2.6%
2/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Nervous system disorders
Syncope
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Product Issues
Device failure
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Psychiatric disorders
Anxiety
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Psychiatric disorders
Anxiety disorder
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Psychiatric disorders
Confusional state
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Psychiatric disorders
Hallucination
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Psychiatric disorders
Mental status changes
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Renal and urinary disorders
Acute kidney injury
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Renal and urinary disorders
Renal failure
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Renal and urinary disorders
Urinary bladder rupture
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Renal and urinary disorders
Urinary retention
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
7.0%
8/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
4.4%
5/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
5.1%
4/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
4.3%
5/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.8%
2/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
6.4%
5/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
2.6%
2/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
2.6%
3/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
2.6%
2/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Vascular disorders
Deep vein thrombosis
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Vascular disorders
Lymphoedema
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
Other adverse events
| Measure |
Ceritinib (Pre-treatment)
Ceritinib 750 mg
|
Chemotherapy (Pre-treatment)
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib (Pre-treatment)
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
Ceritinib (On-treatment)
n=115 participants at risk
Ceritinib 750 mg
|
Chemotherapy (On-treatment)
n=113 participants at risk
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib (On-treatment)
n=78 participants at risk
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
Ceritinib (Survival Follow-up)
Ceritinib 750 mg
|
Chemotherapy (Survival Follow-up)
Chemotherapy as determined by BIRC
|
Chemotherapy/Ceritinib (Survival Follow-up)
Patients randomized to chemotherapy who crossed over to ceritinib at the extension treatment phase
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
6.1%
7/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
17.7%
20/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
10.3%
8/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
5.3%
6/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Blood and lymphatic system disorders
Leukopenia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
2.6%
3/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
8.0%
9/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
7.7%
6/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Blood and lymphatic system disorders
Neutropenia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
5.2%
6/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
22.1%
25/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
7.7%
6/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Gastrointestinal disorders
Abdominal pain
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
25.2%
29/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
8.8%
10/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
25.6%
20/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
19.1%
22/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
4.4%
5/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
14.1%
11/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Gastrointestinal disorders
Constipation
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
21.7%
25/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
13.3%
15/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
25.6%
20/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Gastrointestinal disorders
Diarrhoea
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
73.0%
84/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
18.6%
21/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
73.1%
57/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Gastrointestinal disorders
Dyspepsia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
5.2%
6/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
2.6%
2/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Gastrointestinal disorders
Dysphagia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
2.6%
3/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
2.7%
3/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
5.1%
4/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Gastrointestinal disorders
Nausea
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
63.5%
73/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
23.9%
27/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
59.0%
46/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Gastrointestinal disorders
Stomatitis
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
7.0%
8/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
13.3%
15/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
6.4%
5/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Gastrointestinal disorders
Vomiting
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
53.0%
61/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
8.0%
9/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
47.4%
37/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
General disorders
Asthenia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
25.2%
29/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
16.8%
19/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
16.7%
13/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
General disorders
Fatigue
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
29.6%
34/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
28.3%
32/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
21.8%
17/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
General disorders
Malaise
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
6.1%
7/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
4.4%
5/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
9.0%
7/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
General disorders
Non-cardiac chest pain
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
13.9%
16/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
3.5%
4/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
14.1%
11/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
General disorders
Oedema peripheral
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
5.2%
6/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
9.7%
11/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
6.4%
5/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
General disorders
Pain
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
7.0%
8/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.8%
2/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
6.4%
5/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
General disorders
Pyrexia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
16.5%
19/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
14.2%
16/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
17.9%
14/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Bronchitis
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
3.5%
4/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
3.5%
4/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
5.1%
4/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Cystitis
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
5.1%
4/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Influenza
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
6.1%
7/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
2.6%
2/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Nasopharyngitis
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
11.3%
13/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.8%
2/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
7.7%
6/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Oral candidiasis
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
5.2%
6/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
2.7%
3/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Pneumonia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
5.2%
6/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
6.4%
5/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Respiratory tract infection
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
6.1%
7/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
3.8%
3/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Upper respiratory tract infection
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
2.6%
3/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
3.5%
4/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
6.4%
5/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Infections and infestations
Urinary tract infection
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
3.5%
4/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
7.7%
6/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Investigations
Alanine aminotransferase increased
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
45.2%
52/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
8.8%
10/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
37.2%
29/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Investigations
Amylase increased
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
6.1%
7/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
2.7%
3/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
6.4%
5/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Investigations
Aspartate aminotransferase increased
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
38.3%
44/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
4.4%
5/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
32.1%
25/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Investigations
Blood alkaline phosphatase increased
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
24.3%
28/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
15.4%
12/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Investigations
Blood creatinine increased
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
20.9%
24/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
26.9%
21/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Investigations
Electrocardiogram QT prolonged
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
12.2%
14/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
10.3%
8/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Investigations
Gamma-glutamyltransferase increased
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
23.5%
27/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
2.7%
3/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
23.1%
18/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Investigations
Lipase increased
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
6.4%
5/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Investigations
Neutrophil count decreased
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.87%
1/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
7.1%
8/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Investigations
Weight decreased
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
32.2%
37/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
6.2%
7/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
16.7%
13/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Investigations
White blood cell count decreased
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.7%
2/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
6.2%
7/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
43.5%
50/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
20.4%
23/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
32.1%
25/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
7.8%
9/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
2.7%
3/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
6.4%
5/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
3.5%
4/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.8%
2/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
6.4%
5/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
10.4%
12/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.88%
1/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
9.0%
7/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
20.0%
23/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
14.2%
16/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
16.7%
13/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
23.5%
27/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
8.0%
9/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
12.8%
10/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
3.5%
4/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
4.4%
5/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
6.4%
5/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
9.6%
11/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
3.5%
4/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
3.8%
3/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
5.2%
6/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
12.4%
14/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
7.7%
6/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
7.0%
8/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.8%
2/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
7.0%
8/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
6.2%
7/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
5.1%
4/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Nervous system disorders
Dizziness
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
11.3%
13/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
7.1%
8/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
12.8%
10/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Nervous system disorders
Headache
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
24.3%
28/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
15.9%
18/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
20.5%
16/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Nervous system disorders
Neuropathy peripheral
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.7%
2/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
8.0%
9/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.3%
1/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Nervous system disorders
Paraesthesia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
2.6%
3/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
5.3%
6/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Nervous system disorders
Somnolence
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
4.3%
5/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
2.7%
3/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
6.4%
5/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Nervous system disorders
Tremor
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
5.2%
6/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
9.0%
7/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Psychiatric disorders
Anxiety
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
3.5%
4/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
4.4%
5/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
9.0%
7/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Psychiatric disorders
Insomnia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
9.6%
11/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
11.5%
13/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
7.7%
6/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Renal and urinary disorders
Pollakiuria
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.8%
2/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
5.1%
4/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
17.4%
20/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
17.7%
20/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
16.7%
13/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
15.7%
18/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
15.9%
18/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
16.7%
13/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
5.3%
6/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
0.00%
0/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
4.3%
5/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
3.5%
4/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
5.1%
4/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.7%
2/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
3.5%
4/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
9.0%
7/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
6.1%
7/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
6.2%
7/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
7.7%
6/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.7%
2/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
5.3%
6/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
2.6%
2/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
5.2%
6/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
21.2%
24/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
2.6%
2/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
5.2%
6/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
1.8%
2/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
5.1%
4/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
12.2%
14/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
6.2%
7/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
7.7%
6/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Skin and subcutaneous tissue disorders
Rash
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
13.0%
15/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
11.5%
13/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
19.2%
15/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
|
Vascular disorders
Hypertension
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
3.5%
4/115 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
3.5%
4/113 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
6.4%
5/78 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
—
0/0 • From day of first dose of study medication to last dose of study medication plus 30 days, up to approximately 8 years. Deaths were also collected in the survival follow-up phase from 31 days after last dose of study medication until the end of the study, up to approximately 2.5 additional years. These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival included participants who entered the survival follow-up period. In the on-treatment and survival follow-up periods, patients were analyzed according to the treatment received. Serious and non-serious adverse events were not assessed in the pre-treatment arms/groups.
|
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 pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER